Ashurst et al.v.Britto et al. V. Ashurst et al. V. Ashurst et al. V. Brugger et al.

Board of Patent Appeals and Interferences

Jul 16, 2008

09506834 - (M) (B.P.A.I. Jul. 16, 2008)

BoxInterferences@uspto.gov Paper 83 1
Telephone: 571-272-4683 Entered: 16 July 2008 2
3
UNITED STATES PATENT AND TRADEMARK OFFICE 4
BOARD OF PATENT APPEALS AND INTERFERENCES 5
____________________ 6
7
Patent Interference 105,482 McK 8
Technology Center 1600 9
____________________ 10
11
IAN C. ASHURST, IGNATIUS LOY BRITTO, 12
CRAIG STEVEN HERMAN, LI LI-BOVET 13
and MICHAEL THOMAS RIEBE, 14
15
Patent 6,511,652 B1, 16
Junior Party, 17
18
v. 19
20
FRANCOIS BRUGGER and ANGELIKA STAMPF, 21
22
Application 10/424,633, 23
Senior Party, 24
____________________ 25
26
Before: FRED E. McKELVEY, Senior Administrative Patent Judge, and 27
JAMESON LEE and SALLY C. MEDLEY, Administrative Patent Judges. 28
29
McKELVEY, Senior Administrative Patent Judge. 30
31
DECISION ON MOTIONS 32
A. Statement of the case 33
The interference is before a motions panel for a decision on motions. 34
As declared, the interference involved four Ashurst patents versus a 35
single Brugger application. 36
2
Three of the patents have been removed from the interference. See 1
First Redeclaration (Paper 80). 2
Ashurst Motion 1 3
Ashurst Motion 1 seeks to substitute a new count (which we will refer 4
to as proposed Count A) for Count 1. Paper 31. 5
Brugger timely opposed. Paper 48 (substituted for Paper 37). 6
Ashurst timely replied. Paper 51. 7
Ashurst Motion 2 8
Assuming arguendo that Ashurst Motion 1 is denied, Ashurst 9
Motion 2 seeks to have claims 26-27 of its U.S. Patent 6,546,928 B1 10
[Ex 1003] designated as not corresponding to Count 1. 11
The motion further seeks to have claims 1-24 (all of the claims) of its 12
U.S. Patent 6,511,653 B1 [Ex 1005] designated as not corresponding to 13
Count 1. Paper 32. 14
Brugger timely opposed. Paper 38. 15
Ashurst timely replied. Paper 50. 16
The two Ashurst patents are no longer involved in this interference. 17
Accordingly, in this interference, Ashurst Motion 2 is dismissed. 18
The motion is considered as to U.S. Patent 6,546,928 B1 in 19
Interference 105,626. 20
Brugger Substitute Motion 1 21
Brugger Substitute Motion 1 seeks to have claims 2-14 of Ashurst 22
U.S. Patent 6,532,955 B1 [Ex 1002] designated as corresponding to Count 1. 23
The motion further seeks to have claim 2-14 of Ashurst U.S. Patent 24
6,546,928 B1 [Ex 1003] designated as corresponding to Count 1. 25
The motion still further seeks to have claims 21 and 23 of Ashurst 26
U.S. Patent 6,532,652 designated as corresponding to Count 1. Paper 33. 27
3
Ashurst timely opposed. Paper 40. 1
Brugger timely replied. Paper 52. 2
Ashurst U.S. Patent 6,532,955 B1 and U.S. Patent 6,546,928 B1 are 3
no longer involved in this interference. 4
Accordingly, as to those two patents, in this interference, Brugger 5
Motion 1 is dismissed. 6
The motion is considered as to U.S. Patent 6,532,955 B1 in 7
Interference 105,625. 8
The motion is considered as to U.S. Patent 6,546,928 B1 in 9
Interference 105,626. 10
Brugger Motion 2 11
Brugger Motion 2 seeks to exclude from evidence all or portions of 12
the following Exhibits: 13
2008 14
2028 15
2030 16
2031 17
2033 18
2034 19
2053 20
2058. 21
Paper 55. 22
Ashurst timely opposed. Paper 56. 23
Brugger timely replied. Paper 57. 24
C. Abbreviations 25
The following abbreviations are used in this opinion. 26
FEP means fluorinated ethylene propylene polymer. 27
Glaxo and GSK mean GlaxoSmithKline. 28
4
HFA means a propellant having fluorine, but not chlorine, in 1
its molecular structure. Transcript of Oral Argument, Paper 82, 2
page 20:25-21:3. 3
HFC means a propellant having both fluorine and chlorine in its 4
molecular structure. Paper 82, page 20:4-8. 5
MDI means metered dose inhaler. 6
PAI means a polyamideimide—a polymer having both amide and 7
imide groups. 8
PES means a polymer of polyethersulfone. 9
PFA means a polymer of perfluoroalkoxyalkane. 10
Propellant 134a means tetrafluoroethane. 11
Propellant 227 means 1,1,1,2,3,3,3-heptafluoropropane. 12
PTEF means a polymer of polytetrafluoroethylene. 13
TEF means the same as PTEF. 14
15
D. Count and claims 16
Count 1 17
Count 1 in this interference reads as follows: 18
Ashurst 6,532,955 claim 1 19
or 20
Brugger 10/424,633 claim 9. 21
Paper 1, page 3. 22
Brugger claims 9-10 23
Brugger claim 9 reads [Ex 1010, page 2; emphasis and material in 24
brackets added]: 25
A system for metering and administering an aerosol 26
formulation of a pharmaceutically active ingredient comprising: 27
5
[1] a capped or sealed container having a mouth and a 1
wall with an internal surface, wherein said internal surface is 2
coated with a polymer coating which inhibits the 3
pharmaceutically active agent from depositing thereon; 4
[2] a metering valve system; and 5
[3] an aerosol formulation comprising a 6
pharmaceutically active ingredient formulated with a 7
fluorohydrocarbon propellant. 8
The breadth of Brugger claim 9 is apparent—apart from limiting the 9
polymer coating to one which adheres to the inside of an MDI, claim 9 does 10
not otherwise limit the "polymer" forming part of the "polymer coating." 11
Brugger claim 10, which is designated as corresponding to Count 1, 12
reads [Ex 1010, page 2]: 13
The system of claim 9, wherein in the polymer coating 14
comprises polytetrafluoroethylene or 15
perfluorethylenepropylene. 16
Ashurst claim 1 17
Ashurst claim 1 reads as follows (Ex 1002, col. 9:11-18) (emphasis 18
added): 19
A metered dose inhaler having part or all of its internal 20
surfaces coated with one or more fluorocarbon polymers, 21
optionally in combination with one or more non-fluorocarbon 22
polymers, for dispersing an inhalation drug formulation, 23
comprising a particulate drug and a fluorocarbon propellant, 24
optionally in combination with one or more other 25
pharmacologically active agents or one or more excipients. 26
6
The presence of the "optionally" limitations in claim 1 essentially 1
makes the claim simultaneously an independent claim and a dependent 2
claim. We find it unnecessary to voice any opinion on whether claim 1 is 3
proper under 35 U.S.C. § 112. 4
Both a claim involved in, and a count of, an interference are given 5
their broadest reasonable interpretation. See 37 C.F.R. § 41.200(b) (2007) 6
(as to claims); Schwab v. Pittman, 59 CCPA 720, 723, 451 F.2d 637, 639 7
(CCPA 1971) (as to counts). 8
The broadest reasonable interpretation of Ashurst claim 1 is the 9
following (essentially Ashurst claim 1 sans the "optionally" limitations): 10
Claim A: A metered dose inhaler having part or all of its 11
internal surfaces coated with one or more fluorocarbon 12
polymers for dispersing and inhalation drug formulation, 13
comprising a particulate drug and a fluorocarbon propellant. 14
Unlike Brugger claim 9 (polymer coating), Ashurst claim 1 is limited 15
to internal surfaces coated with at least a fluorocarbon polymer. 16
One possible embodiment within Ashurst claim 1, which includes one 17
of the "optionally" limitations, would be narrower and would read (emphasis 18
added): 19
Claim B: A metered dose inhaler having part or all of its 20
internal surfaces coated with a blend coating comprising 21
(1) one or more fluorocarbon polymers and (2) one or more 22
non-fluorocarbon polymers, for dispersing and inhalation drug 23
formulation, comprising a particulate drug and a fluorocarbon 24
propellant. 25
We use "blend coating" in Claim B because that is the phrase used by 26
Ashurst in its motion. See, e.g., Paper 31, page 7:12. 27
7
As will become apparent, it is the subject matter of Claim B which is 1
of interest to Ashurst. 2
As we understand Ashurst's position, it concedes priority of the 3
subject matter of Claim A to Brugger, Ashurst having had advised the Board 4
that it does not intend to offer proofs on priority. Paper 24, page 3:3-6; 5
Paper 31, page 1:8-10; Paper 77, page 4:13-16. 6
E. Ashurst Motion 1 and Brugger Substitute Motion 1 7
Ashurst Motion 1 seeks to substitute a new count (Proposed Count A) 8
for Count 1. 9
In addition, it is readily apparent that both Ashurst Motion 1 10
(Paper 31) and Brugger Substitute Motion 1 (Paper 33) raise common issues 11
concerning whether certain Ashurst patent claims should be designated as 12
corresponding to the count. 13
Because the motions raise some common issues, we have considered 14
both motions together. 15
Ashurst Motion 1 (Paper 31), Brugger Substitute Opposition 1 (Paper 16
48) and Ashurst Reply 1 (Paper 51) are not models of clarity. 17
Accordingly, we asked the parties to file additional briefs. Paper 65. 18
Both Ashurst and Brugger accepted our invitation to file supplemental 19
briefs. Paper 77 (Ashurst) and Papers 68-74 (Brugger). 20
The Board expresses its appreciation to the parties and counsel for the 21
additional briefs. 22
Upon consideration of Ashurst Motion 1 (Paper 31), Brugger 23
Substitute Opposition 1 (Paper 48), Ashurst Reply 1 (Paper 51), the 24
additional briefs (Ashurst Paper 77 and Brugger Papers 68-74), Brugger 25
Substitute Motion 1 (Paper 33), Ashurst Opposition 1 (Paper 40), and 26
8
Brugger Reply 1 (Paper 52), we feel comfortable that we can get to the 1
merits of the relief sought by Ashurst and Brugger. 2
Ashurst proposes to substitute Proposed Count A for Count 1 3
[bracketed material, emphasis, and some indentation added]: 4
Proposed Count A 5
[1] An aerosol container for pharmaceutically active 6
aerosols that are to be administered in predetermined amounts 7
and that are supplied in the container in the form of a 8
suspension, 9
[2] the suspension also comprising, in addition to a 10
pharmaceutically active substance, at least a propellant gas, 11
[3] which aerosol container has a metering valve that 12
comprises a metering chamber and a valve stem, 13
[4] the metering chamber being in communication with 14
the interior of the container and being full of a predetermined 15
amount of the aerosol in a first position of the valve stem, and 16
releasing the amount of aerosol disposed in the metering 17
chamber in a second position of the valve stem, 18
[5] wherein the propellant gas is an alternative propellant 19
gas that is free of fluorochlorohydrocarbons and, where 20
appropriate, also cosolvents and/or surfactants, and 21
[6] wherein the inner wall of the container is coated with 22
a plastics coating, wherein the plastics coating disposed on the 23
inner wall of the container is a fluorocarbon polymer. 24
Paper 31, page 20:1-13. 25
26
27
9
The issue 1
Proposed Count A defines the plastic coating as a "fluorocarbon 2
polymer." Paper 31, page 20:15-16. 3
As to Ashurst, it turns out that MDIs coated with fluorocarbon 4
polymers are old. See Canadian patent application 2,120,867 [Canada 867], 5
Ex 2010: (1) last page, drawing element 3; (2) page number -3-, last ¶, 6
line 2, and (3) page number -2-, last full ¶, last line. 7
Canada 867 is prior art vis-à-vis Ashurst. While Ashurst hinted that it 8
might have made its invention prior to the date Canada 867 was published, 9
at oral argument Ashurst conceded the prior art status of Canada 867. 10
Accordingly, it has waived any right it had to establish prior invention—11
either through an antedating effort (37 C.F.R. § 1.131) or priority (35 U.S.C. 12
§ 102(g)(1)). See Transcript of Oral Argument, Paper 82, page 16:3-26. 13
A typical fluoropolymer is a polymer of tetrafluoroethylene, the 14
polymer being known as PTFE [PolyTetraFluoroEthylene]. Ex 1004, 15
col. 4:26-29. 16
The formula of tetrafluoroethylene is: 17
CF2═CF2 18
PTEF results from polymerization of tetrafluoroethylene and can be 19
represented by the formula: 20
―(CF2―CF2)n―. 21
The length of the polymer chain is dependent upon the value of "n" 22
which represents the degree of polymerization. See Ex 1036, second page, 23
Chart I, first polymer. 24
PTEF is made up essentially of carbon [C] and fluorine [F]. 25
PTEF is sold under the well-known registered Trademark TEFLON®. 26
10
Ashurst claims 1-22 and 24-25 are not limited to MDIs with a blend 1
coating. Ex 1004, col. 10:2 through col. 12:41. 2
On the other hand, Ashurst claim 23 calls for MDIs [indentation 3
added]: 4
having part or all of its internal surfaces coated with a polymer 5
blend comprising 6
(i) one or more fluorocarbon polymers comprising 7
monomeric units made from one or more monomers selected 8
from the group consisting of tetrafluoroethylene [illustrated 9
above], hexafluoropropylene [i.e., CF2═CF―CF3], 10
perfluoroalkoxyalkylene, and vinylidene fluoride in 11
combination with 12
(ii) one or more nonfluorocarbon polymers selected 13
from the group consisting of a polyamide, a polyimide, a 14
polyamideimide, a polyethersulphone, a polyphenylene sulfide 15
and an amine-formaldehyde thermosetting resin. 16
Because Ashurst claim 23 calls for a blend coating including a 17
nonfluorocarbon polymer, Ashurst maintains that the subject matter of 18
Ashurst claim 23 is patentably distinct (35 U.S.C. § 103) from proposed 19
Count A and therefore should be designated as not corresponding to 20
proposed Count A. 21
When the interference was declared, Ashurst claim 23 was designated 22
as not corresponding to Count 1. Paper 1, page 4:20. 23
Ashurst claim 21 also was initially designated as not corresponding to 24
Count 1. Paper 1, page 4:20. According to Ashurst Motion 1, claim 21 25
should be designated as corresponding to proposed Count A. See Paper 31, 26
page 22, Table following line 2 and Table following line 14. 27
11
Accordingly, Ashurst claim 21 will be designated as corresponding to 1
any new count. 2
Brugger opposes the motion to substitute Count A for Count 1, 3
maintaining inter alia that Count 1 "more precisely defines the interfering 4
subject matter." Paper 48: page 18:13-15. 5
Brugger argues that the subject matter of claim 23 is not patentably 6
distinct (35 U.S.C. §§ 102 and 103) from proposed Count A. Paper 48, 7
page 20:21-24. 8
Ashurst has the burden of proof with respect to its motion. 9
Preserving the issue of whether Ashurst claim 23 should be involved 10
in the interference in the event Ashurst Motion 1 is denied, Brugger 11
Motion 1 seeks to have Ashurst claim 23, along with Ashurst claim 21, 12
designated as corresponding to Count 1. Paper 33, page 1:4 and 13
page 32:5-8. 14
Brugger has the burden of proof with respect to its motion. However, 15
if the Ashurst motion to designate Ashurst claim 23 as not corresponding to 16
the count is denied, then the Brugger motion can be granted pro forma. 17
Brugger Substitute Motion 1 is moot to the extent it seeks to have 18
Ashurst claim 21 designated as corresponding to the count because Ashurst 19
now agrees. 20
The issues are: 21
(1) Should Proposed Count A (or some other appropriate 22
count, e.g., Count B) be substituted for Count 1? 23
(2) If so, should Ashurst claim 23 be designated as not 24
corresponding to Proposed Count A (or some other appropriate count)? 25
12
Facts 1
1. Background of the Ashurst invention 2
Ashurst reveals that prior to its invention "metered dose inhalers" 3
were known. Ex 1004, col. 1:14-39; Paper 82, page 4:18-19. 4
Metered dose inhalers are also referred to in the record as an MDI." 5
An MDI is an aerosol-type device that is designed to deliver uniform 6
doses of an active ingredient (drug) to a patient, or in the words of the 7
Ashurst patent, "every dose in the can must be the same within close 8
tolerances." Ex 1004, col. 1:46-47; Paper 82, page 4:20-23. 9
An MDI is shown and described in Canada 867. Ex 2010, last page 10
(drawing) and page 2, last ¶ through page 3, first full ¶ (description). 11
We are told that uniform doses within close tolerances are an 12
objective of a pharmaceutical manufacturer attempting to comply with 13
requirements of the Food and Drug Administration (FDA). Ex 1004, 14
col. 1:41-46. See also Paper 77, page 7:6-8. 15
A propellant is present inside the MDI. 16
There was a time when chlorofluorocarbons were used as propellants. 17
Ex 1004, col. 1:55. 18
Chlorofluorocarbons are compounds having the following atoms: 19
carbon [C], chlorine [Cl], fluorine [F] and sometimes hydrogen [H]. 20
At the time of Ashurst's invention it was known that 21
chlorofluorocarbons caused damage to the ozone layer. Ex 2010, page 2, 22
last full ¶; Ex 2051, European patent application 0 372 777 A2, 23
page 2:21-55. See also Paper 77, page 6:17-20; Paper 82, page 5:1-4. 24
As a result, industry, including the MDI industry, replaced 25
chlorofluorocarbon propellants with non-chlorine containing fluorocarbon 26
13
propellants. Ex 2010, page 2, last full ¶; Ex 1004, col. 1:52-55. See also 1
Paper 77, page 6:17-20. 2
When the MDI industry switched to fluorocarbon propellants, a 3
problem developed because the active ingredient—the drug—had a tendency 4
to adhere to the inner wall of the MDI. See Paper 77, page 6:20 through 5
page 7:2. 6
Generally, the MDI wall is made of metal—often aluminum. 7
According to Ashurst, the problem was "particularly acute with 8
hydrofluoroalkanes" (fluorocarbons). Ex 1004, col. 1:49-56. 9
We are told that aerosols using a fluorocarbon propellant were more 10
susceptible to irreversible deposition on the can wall. Britto declaration, 11
Ex 2008, page 2:21-22. 12
We understand "irreversible deposition" to mean that the active drug 13
ingredient adheres (i.e., sticks,) to the inside surface of the MDI. 14
The more an active ingredient adheres to the inside surface of the 15
MDI, the less likely the dose will remain uniform throughout the life of the 16
MDI—because some of the active ingredient sticks on the wall and is no 17
longer available to be delivered to a patient by the MDI. See generally 18
Paper 77, page 7:2-5. 19
Since they have similar sounding chemical names, we pause to 20
briefly clarify the difference between (1) a fluorocarbon propellant and (2) a 21
fluorocarbon polymer. 22
A fluorocarbon propellant is a compound generally containing only 23
carbon, fluorine and hydrogen atoms. 24
An example of a fluorocarbon propellant is 1,1,1,2-tetrafluoroethane, 25
a compound having a relatively low molecular weight and the formula: 26
CF3―CFH2. 27
14
1,1,1,2-tetrafluoroethane is also known as P134a or propellant 134a. 1
Ex 1004, col. 3:48-49; Britto declaration, Ex 2008, page 2:16. 2
Another fluorocarbon propellant is 1,1,1,2,3,3,3-heptafluoropropane, 3
which has the formula: 4
CF3―CF―CF3 5
and is otherwise known as propellant 227. Ex 2008, page 2:16-17. 6
We are told that these two fluorocarbon propellants are the only two 7
approved for use in MDIs. Ex 1007, page 20, ¶ 105. 8
A fluorocarbon polymer is a solid polymeric substance having a 9
relatively high molecular weight. 10
As noted earlier in this opinion, in the case of polytetrafluoroethylene, 11
the formula is 12
―(CF2―CF2)n―. 13
The molecular weight is a function of the value of "n" with large "n" 14
values resulting in higher molecular weight polymers. 15
2. Ashurst's invention 16
We are told that prior to the Ashurst invention, as well as the Brugger 17
invention, research efforts failed to solve the drug deposition problem. See 18
Paper 77, page 7:5-6. 19
Ashurst sought to overcome the adherence problem by coating the 20
interior surface of the MDI with a fluorocarbon polymer. 21
According to Ashurst, coating the interior surface with a fluorocarbon 22
polymer "significantly reduces or essentially eliminates the problem of drug 23
adhesion or deposition on the [interior surface of the] can walls and thus 24
ensures consistent delivery of medication in aerosol form from the MDI." 25
Ex 1004, col. 1:57-61. 26
15
Ashurst specifically reveals that an MDI having an interior surface 1
coated with one or more fluorocarbon polymers, optionally in combination 2
with one or more non-fluorocarbon polymers, is suitable for dispersing a 3
drug formulation having the active ingredient beclomethasone dipropionate. 4
Ex 1004, col. 1:64 through col. 2:5. 5
` Identified as suitable fluorocarbon polymers are polytetrafluoro-6
ethylene (PTFE) and fluorinated ethylene propylene polymers (FEP). 7
Ex 1004, col. 4:26-35. 8
The polymer is coated on to the interior surface of an MDI can which 9
is generally made of metal, and in particular aluminum or an alloy of 10
aluminum. Ex 1004, col. 4:59-61. 11
The MDIs with fluorocarbon coated interiors described by Ashurst are 12
said to useful in medical practice in a manner similar to non-coated MDIs 13
previously in commercial use. Ex 1004, col. 6:51-53. 14
Ashurst also reveals: 15
The fluorinated polymer may be blended with non-16
fluorinated polymers such as polyamides, polyimides, 17
polyethersulfones, polyphenylene sulfides and amino-18
formaldehyde thermosetting resins. These added polymers 19
improve adhesion of the polymer coating to the can walls. 20
Preferred polymer blends are PTFE/FEP/polyamideimide, 21
PTFE/polyethersulphone (PES) and FEP-benzoguanamine. 22
Ex. 1004, col. 4:36-43. 23
While Ashurst mentions several blends of polymers, specifically 24
mentioned are (1) PTFE-PES DuPont 3200-100 and (2) PTFE-FEP-25
polyamideimide DuPont 856P23485. Ex 1004, col. 4:52-53. 26
16
Examples 1 through 42 appear in the specification. Ex 1004, col. 7:8 1
through col. 9:67. 2
Examples 1 and 2, presented in the "past tense" presumably are based 3
on actual experimentation. 4
The remaining examples presented in the "present tense" presumably 5
are prophetic. 6
Prophetic Example 3 describes an MDI can "spray-coated with 7
PTEF-PES blend (DuPont) as a single coat and cured according to the 8
vendor's standard procedure." Ex 1004, col. 7:35-36. 9
Insofar as we can tell, the "vendor's standard procedure" does not 10
appear in the record, albeit there is some DuPont literature in the record. 11
Ex 1082, Ex 1083 and Ex 1084. 12
Prophetic Examples 8 and 13 also describe MDI's made with a 13
DuPont blend comprising PTEF-PES. Ex 1004, col. 8 and col. 9. 14
3. Ashurst claims 1-25 15
The only claim in Ashurst Patent 6,511,652 B1 which Ashurst seeks 16
to have designated as not corresponding to proposed Count A is Ashurst 17
claim 23. Paper 31, page 22, last line. 18
Ashurst claim 23 reads [material in brackets and some indentation 19
added]: 20
A metered dose inhaler system, comprising: 21
a metered dose inhaler comprising: 22
[1] a can having a mouth, said can having part or all of 23
its internal surfaces coated with a polymer blend comprising 24
25
(i) one or more fluorocarbon polymers comprising 26
monomeric units made from one or more monomers 27
selected from the group consisting of tetrafluoroethylene, 28
17
hexafluoropropylene, perfluoroalkoxyalkylene, and 1
vinylidene fluoride in combination with 2
3
(ii) one or more nonfluorocarbon polymers 4
selected from the group consisting of a polyamide, a 5
polyimide, a polyamideimide, a polyethersulphone, a 6
polyphenylene sulfide and an amine-formaldehyde 7
thermosetting resin; 8
9
[2] a cap in communication with the mouth of the can, 10
the cap containing a drug metering valve capable of metering an 11
inhalation medicament formulation; and 12
13
[3] an inhalation medicament formulation, comprising 14
0.005 to 10% by weight of beclomethasone dipropionate or a 15
physiological accepted solvate thereof relative to the total 16
weight of said inhalation medicament formulation formulated 17
with a fluorocarbon propellant, said fluorocarbon propellant is 18
selected from the group consisting of 1,1,1,2-tetrafluoroethane 19
or 1,1,1,2,3,3,3-heptafluoro-n-propane and combinations 20
thereof; and 21
22
[4] a channeling device in communication with said 23
metered dose inhaler, said channeling device comprising an 24
actuating device for the valve and a cylindrical or cone shaped 25
passage through which medicament is delivered from the 26
metered dose inhaler. 27
28
4. Prior art 29
(1) Canada 867 30
Ordinarily in assessing whether a claim should be designated as 31
corresponding to a count, an evaluation is made as to whether the subject 32
matter of the claim is patentably distinct from the subject matter of the 33
count. 34
"Patentably distinct" means that the subject matter of the claim is not 35
anticipated (35 U.S.C. § 102) by or rendered obvious (35 U.S.C. § 103) over 36
18
the subject matter of the count (either alone or in combination with other 1
prior art). 2
The subject matter of the count is presumed to be prior art on an 3
interlocutory assumption that the opponent will prevail on priority. 4
If the party ultimately prevails on priority, then the party's claim 5
correspondence is a moot issue—the party is entitled to the claim apart from 6
priority, provided of course that the claim is otherwise patentable. 7
If the opponent ultimately does not prevail on priority, then the party 8
is not entitled to claims designated as corresponding to the count—such 9
claims being "involved" in the interference within the meaning of 10
35 U.S.C. § 135(a); 37 C.F.R. § 41.207(b) (2007). 11
As earlier noted, Ashurst has indicated that it will not contest priority. 12
Paper 24, page 3:3-6; Paper 31, page 1:8-10; Paper 77, page 4:14-16. 13
Accordingly, the subject matter of the count is prior art vis-à-vis 14
Ashurst and there is no longer any need to assume that Brugger will prevail 15
on priority. 16
Under the facts of this case, all of the subject matter of the involved 17
Brugger application is prior art, not just the subject matter of Brugger 18
claim 9. 19
Why? Because, Canada 867 (Ex 2010) has essentially the same 20
disclosure as the involved Brugger application and Ashurst does not contest 21
the prior art status of Canada 867. 22
The parallel between Canada 867 and the Ashurst specification 23
becomes manifest upon a study of Canada 867. 24
Canada 867 reveals that the use of MDIs was known. Ex 2010, 25
page 1, 2d and 3d full ¶¶. 26
19
Canada 867 reveals, as does Ashurst, that fluorochlorohydrocarbons 1
when used a propellants caused environmental damage to the ozone layer. 2
Ex 2010, page 1, 4th full ¶. 3
Apart from the propellant used, Canada 867 reveals, as does Ashurst, 4
that one problem encountered in using MDIs with fluorochlorohydrocarbons 5
propellants was pharmaceutically active ingredients being deposited on the 6
inner wall of the MDI. Ex 2010, page 2, 2d full ¶. 7
Canada 867, like Ashurst, sought to solve the deposit problem by 8
coating the inner wall of the MDI with a "plastic." 9
Polytetrafluoroethylene, e.g., Teflon®, is said to be "[e]specially 10
advantageous." Ex 2010, page 2, 2d full ¶. 11
The coating on the inner wall is shown as element 3 in the drawings. 12
Ex 2010, page 3, last ¶, line 2. 13
Canada 867, like Ashurst, describes the use of tetrafluoroethane and 14
heptafluoropropane propellants. Ex 2010, page 5, 2d full ¶, lines 1-2. 15
As noted earlier, these two propellants are approved by the FDA for 16
use in MDIs. Ex 1007, page 20, ¶ 105. 17
What are the differences between Ashurst claim 23 and Canada 867? 18
Difference 1. The most significant difference, and the difference upon 19
which Ashurst bottoms its case, is that Canada 867 does not describe the use 20
of a combination of (1) a fluorocarbon polymer and (2) a nonfluorocarbon 21
polymer identified in Markush group (ii) set out in Ashurst claim 23. 22
See also Paper 77, page 7:10-15. 23
Difference 2. Another difference is that Canada 867 does not describe 24
the use of an MDI to administer beclomethasone dipropionate. 25
20
(2) European patent application 0 372 777 A2 1
The European patent application reveals why Difference 2 is 2
relatively insignificant. 3
The European patent application (Ex 2051) describes metered dose 4
inhalers (page 2:10) for administering beclomethasone dipropionate 5
(page 5:59) using as a propellant 1,1,1,2-tetrafluoroethane (P134a) 6
(page 6:6). See also (1) Purewal, U.S. Patent 5,225,183 (06 July 1993), 7
Ex 1018, col. 1:14; col. 1:56-57; col. 2:15; col. 5:66; col. 6:67; col 10:2-3; 8
and col. 10:20 and (2) Dalby, U.S. Patent 5,202,110 (13 April 1993), 9
Ex 1021, col. 1:10; col. 2:4-5; col. 2:32; and col. 3:57-59. 10
(3) British patent specification 1,228,438 11
British patent specification 1,228,438 (British 438), published 12
15 April 1971, describes coating compositions comprising copolymers of 13
polytetrafluoroethylene (TEF) and hexafluoropropylene (FED) useful as 14
coatings. Ex 2047, page 1:11-14. 15
The compositions are said to be suitable for direct use as coating 16
compositions which can be applied by "spraying" (Ex 2047, page 3:20-25). 17
While illustrative uses are kitchen utensils and ice-cube trays, 18
British 438 discloses that the compositions prevent "sticking and caking." 19
Ex 2047, page 3:44. 20
"Auxiliary materials" may be included in the coating. Ex 2047, 21
page 3:47-49. 22
The auxiliary materials include, inter alia, (1) aminoplast resins 23
(i.e., resins made from an amine and formaldehyde) and (2) polyamides. 24
Ex 2047, page 3:60-61 and 113 and 117. See also Example 6 describing a 25
coating composition comprising a polymer blend made from (a) TEF/HFP 26
and (b) a melamine-formaldehyde resin. Ex 2047, page 6:20-31. 27
21
A polymer of TEF is also referred to in the record as PTFE. 1
The properties of resulting films made from polymers containing 2
auxiliary materials will vary according to the nature and amount of the 3
auxiliary material. Ex 2047, page 3:62-65. 4
(4) British patent specification 1,230,339 5
British patent specification 1,230,339 (British 339), published on 6
28 April 1971, describes polytetrafluoroethylene-containing coatings on the 7
surfaces of articles. Ex 2048 [also Ex 1043], page 1:11-13. 8
Coated articles are said to have non-stick properties, i.e., "are resistant 9
to substances sticking or adhering to them." Ex 2048, page 1:14-16; Gupta 10
declaration, Ex 1088, page 12-13, ¶ 61. 11
According to British 339, one difficulty with PTFE coatings is 12
"obtaining a coating which is firmly adherent to the surface of the article 13
[to which it is adhered]." Ex 2048, page 1:23-25; Gupta declaration, 14
Ex 1088, page13, ¶¶ 62 and 66. 15
British 339 recognizes that its coatings result in non-uniform coatings 16
which nevertheless have highly desirable properties. Ex 2048, page 1:75-80. 17
As explained by British 339, the predominancy of the PTFE at the 18
outer surface of the coating gives the coating an inert lubricious surface and 19
outstanding release properties. Ex 2048, page 1:83 through page 2:1. 20
The distribution ("stratification") of the fluoropolymer and the non-21
fluoropolymer is discussed in more detail later in this opinion. 22
PTEF is formed in a dispersion which can be applied in a 23
conventional method, such as spraying. Ex 2048, page 2: 123-126. 24
The coating will also have an "auxiliary film-forming material." 25
Ex 2048, page 3:3-4. 26
22
Auxiliary film-forming materials include, inter alia, (1) polyimides, 1
(2) polyamide-imides, (3) polyphenylene ethers and (4) melamine-2
formaldehyde resins. Ex 2048, page 3:6 and 30 and 33. 3
The properties of the resulting films vary with the nature of the 4
auxiliary material and its concentration. Ex 2048, page 3:66-69. 5
The coatings are useful in a variety of field where "quick release is 6
desirable" and where picking up oil and grease is to be minimized. Ex 2048, 7
page 3:70-82. 8
(5) British patent specification 1,537,851 9
British patent specification 1,537,851 (British 851) describes 10
coatings made from polytetrafluoroethylene and polyethersulphones (PES). 11
Ex 2026 [also Ex 1091], page 1:79-85. 12
Polyethersulphones having ―OH end groups are said to give better 13
adhesion than other polyethersulphones. Page 2:75-78. 14
British '851 reveals (Ex 2026, page 3:37-52): 15
The compositions of the invention preferably have 16
tetrafluoroethylene polymer/polyethersulphone … weight ratios 17
between 9:1 and 1:9, particularly between 4:1 and 1:3. 18
As the proportion of the tetrafluoroethylene polymer is 19
increased, the coatings made from the dispersions become 20
softer and more porous and less strongly adherent to the 21
substrate. On the other hand the non-stick properties of the 22
coatings deteriorate as the proportion of polyethersulphone 23
increases. We therefore particularly prefer to employ 24
tetrafluoroethylene polymer/polyethersulphone weight ratios of 25
between 0.75:1 and 2:1, most preferably between 0.9:1 and 26
1.4:1. 27
23
The coating compositions may be applied to a variety of substrates, 1
including aluminum. Ex 2026, page 4:106-117. See also Example 1 2
describing a coating on aluminum (page 5:76). 3
British 851 reveals that properties of its blend coatings are a function 4
of the nature of the polyethersulphone. First, the invention is said to be an 5
improvement of a PTFE/PES invention described in British patent 6
specification 1,426,342 (Ex 1092). Ex 2026, page 1:23-46. Second, the end 7
groups of the polyethersulphone are said to be significant and have an effect 8
on adhesion. Ex 2026, page 2:15-92. Third, satisfactory coatings are said to 9
be obtained when the reduced viscosity is below 0.25. Ex 2026, 10
page 1:79-85, page 2:93-105 and page 4:57-65. Fourth, the particle size 11
should be below 25µm. Ex 2026, page 2:116 through page 3:1. Fifth, the 12
ratio of polytetrafluoroethylene to polyethersulphone is significant. 13
Ex 2026, page 3:42-48 and Table 3 (page 9). Table 1 summarizes some of 14
the properties as a function of some of the variables discussed. Ex 2026, 15
page 7. 16
(6) Ullmann's Encyclopedia 17
Ullmann's Encyclopedia, Ex 1035, page 380, col. 2 (1991), notes the 18
following: 19
Recently, mixtures of PTFE dispersions and heat-20
resistant hydrocarbon polymers (e.g., polyimide, polyether 21
sulfone, or polyphenylene sulfide) have been developed to 22
improve the poor adhesion of fluoropolymer to a substrate and 23
applied as a primer or one-coat enamel. 24
5. Testimony 25
Both parties presented testimony. 26
24
(1) Ignatius Loy Britto 1
Dr. Ignatius Loy Britto testified on behalf of Ashurst. Ex 2008 and 2
Ex 2079. 3
Dr. Britto is Director of Metered Dose Inhaler product development at 4
GlaxoSmithKline in the United States. Ex 2008, page 1:15-16. 5
We assume that there is some connection between GlaxoSmithKline 6
(Glaxo), where Dr. Britto works, and SmithKlein Beecham Corp., the real 7
party in interest. The precise connection is not relevant to the issues before 8
us. 9
Dr. Britto explained that (1) an MDI (presumably a commercial MDI) 10
can be used from 60 to 200 times and (2) the dose each time should be 11
essentially the same. Ex 2008, page 2:6-13; Paper 82, page 4:22-23. 12
Dr. Britto confirms what both the Ashurst patent and the prior art 13
reveal, i.e., there was a need to switch from chlorofluorocarbon propellants 14
to fluorocarbon propellants. Ex 2008, page 2:14-17. 15
According to Dr. Britto, switching from one propellant to the other 16
"created a number of unexpected formulation problems." Ex. 2008, page 17
2:20. 18
One problem was that use of a fluorocarbon resulted in MDIs that 19
"were more susceptible to irreversible deposition on the [MDI] can wall." 20
Ex 2008, page 2:20-22. 21
The problem encountered by Dr. Britto is discussed, and a solution is 22
proposed, in Canada 867. 23
In 1994, Britto says that he was aware that Glaxo had been 24
investigating numerous ways to address drug deposition and dosing. 25
Ex 2008, page 3:5 through 4:9. 26
25
Investigation in, or prior to, 1994 would have taken place before 1
publication of Canada 867. 2
Dr. Britto believes that in January 1994, Glaxo began to look into a 3
possibility of using fluoropolymers (e.g., Teflon®) as a coating on MDIs. 4
Ex 2008, page 4:10-12. 5
Dr. Britto bases his belief on a Glaxo email dated 14 January 1994 at 6
12:42 pm. Ex 2031. 7
Brugger's motion to exclude Ex 2031 is discussed later in this opinion. 8
Dr Britto also notes that as soon as the use of Teflon® was proposed 9
skepticism concerning its use in an MDI is said to have surfaced. Ex 2008, 10
page 4:12-14. 11
Dr. Britto bases his belief on a Glaxo email dated 14 January 1994 12
02:22 p.m. Ex 2033. 13
Confirming the modern marvel of email systems, and assuming the 14
dates and times on the emails are accurate, we see that it took less than 2 15
hours for the Teflon® proposal to be questioned. 16
Brugger's motion to exclude Ex 2033 is discussed later in this opinion. 17
Both the proposal and the skepticism occurred before publication of 18
Canada 867. 19
There came a time, probably in October of 1994 (Ex 2079, 20
page 15:22-23), when Dr. Britto decided that a blend coating made of 21
PTEF/PES or PTFE/FEP/PAI might solve the problem. Ex 2008, 22
page 6:11-14. 23
Significantly, Dr. Britto knew, inter alia, based on his awareness of 24
DuPont literature, that when polymer blends are baked they undergo a 25
degree of "stratification." Ex 2008, page 6:14-16. See also Ex 2079, 26
page 17:2-11. 27
26
Stratification results in the non-fluoropolymer (PES) migrating to the 1
substrate (metal) surface and the fluoropolymer (PTEF) migrating to the top 2
of the coating (surface exposed to interior of MDI). Ex 2008, page 6:16-17. 3
Insofar as we can tell, the record does not contain a copy of the 4
"DuPont literature" to which Dr. Britto refers. 5
Dr. Britto's knowledge about stratification was known in the art after 6
publication of British 339. Ex 2048, page 1:75 through page 2:1. 7
Further confirmation appears in British 851, which reveals in the case 8
of PES [polyethersulfones] better adhesion is said to be obtained with ―OH 9
end groups vis-à-vis other ends groups. Ex 2026, page 2:75-78. See also 10
Ex 1036, page 467 et seq. 11
In order to evaluate various coatings, Dr. Britto states that "tests were 12
conducted." Ex 2008, page 7:10. 13
Test results are set out in a table on page 8 of Ex 2008. 14
The testing is said to have compared use of (1) a PTFE/PES blend 15
coating and a PTFE/FEP/PAI blend coating (falling within the scope of 16
Ashurst claim 23) with (2) FEP non-blend coating (not falling within the 17
scope of Ashurst claim 23). 18
Both the PTFE/PES (79 µgms) and PTFE/FEP/PAI (74 µgms) blend 19
coatings "passed" the Glaxo target which is ≥ 72 µgms. 20
The 72 µmgs target is not an FDA requirement. Ex 2079, 21
page 20:10-19. 22
The FEP non-blend coatings (43 and 66 µgms) "flunked" the Glaxo 23
target. 24
At least the following can be observed about the testing. First, there 25
is no complete description of the PTFE/PES polymer blend. We know from 26
British 851 that properties, including adhesion, are a function of the nature 27
27
of at least the PES. Ashurst claim 23 is not limited to any particular PES. 1
Second, the testing of blends does not include several blends falling within 2
the scope of Markush group (ii) of Ashurst claim 23. Third, there was no 3
comparison with a fluoropolymer which is PTFE—the preferred 4
fluoropolymer described by Canada 867. Ex 2010, page 5, 2d full ¶, line 4. 5
Fourth, Dr. Britto does not describe which FEP was used. 6
(2) Craig S. Herman 7
Dr. Craig S. Herman testified on behalf of Ashurst. Ex 2028 and 8
Ex 2080. 9
At the time of his declaration testimony, Dr. Herman was a Project 10
Manager at GlaxoSmithKline with responsibilities for Global Project and 11
Portfolio Management. Ex 2028, ¶ 3:10-11. 12
In large measure, Dr. Herman confirms the background of the Ashurst 13
invention including the problems with active ingredient (drug) sticking to 14
the side of an MDI. 15
Dr. Herman adds that one of "numerous unforeseen difficulties" was 16
that drugs did not remain in suspension when the industry switched from 17
chlorofluorocarbon propellants to fluorocarbon propellants. Ex 2028, ¶ 6:23 18
through page 2:2. 19
Dr. Herman agrees with Dr. Britto that Glaxo engaged in a wide range 20
of experimental approaches to overcome the "suspension" problem. 21
Ex 2028, page 2:13-18. 22
Dr. Herman appears to base his testimony on two documents. 23
The first document is a MEMO dated 02/03/95 [which we take to 24
mean 03 February 1995]. Ex 2030. 25
Ashurst does not maintain that any of the experimental work reported 26
in Ex 2030 took place prior to publication of Canada 867. 27
28
The second document appears to be an email dated 24 February 1994. 1
Ex 2029. 2
The second document is said to constitute the "initial action plan" 3
mentioned at the bottom of page 2 of Ex 2030. 4
Apparently none of the experimental approaches solved Glaxo's 5
problems. Ex 2028, page 2:19-20 ("None of them did."). 6
We address later in this opinion Brugger's objection to the 7
admissibility of the two documents. 8
Dr. Herman, like Dr. Britto, says the idea of using a fluoropolymer 9
met with speculation. Ex 2028, ¶ 18. 10
According to Dr. Herman, a Dr. Patrick Kaczaral expressed some 11
concerns and suggested that the "experts" at DuPont be consulted. Ex 2028, 12
¶19. 13
We believe that Dr. Kaczaral is the author of Ex 2033. 14
Further according to Dr. Herman, the DuPont experts recommended 15
against use of fluorinated coatings based on their "chemical similarity to the 16
fluorinated propellants." Ex 2028, ¶ 20. 17
Conspicuously absent from Dr. Herman's testimony is when the 18
alleged contact with the DuPont experts occurred. 19
We can surmise on this record that it might have occurred on or about 20
17 January 1994. See, e.g., the handwritten notes on Ex 2033. 21
We give the consultation with DuPont experts little, if any, weight 22
because (1) there is no testimony from (a) any Glaxo employee who 23
consulted with DuPont or (b) any DuPont expert who was consulted, (2) the 24
testimony is hearsay to the extent that Ashurst seeks to have it considered to 25
establish what DuPont experts might have believed, and, perhaps most 26
29
important, (3) any consultation appears to have occurred prior to publication 1
of Canada 867. 2
On this record, it does not seem likely that any pre-1995 DuPont 3
expert would have been aware of Canada 867 which had not yet been 4
published. 5
We cannot tell what any DuPont expert would have said in 1995 had 6
the expert had knowledge of the information contained in Canada 867. 7
(3) Kenneth Batzar 8
Dr. Kenneth Batzar testified on behalf of Ashurst. Ex 2056 (direct) 9
and Ex 2082 (cross-examination). 10
Unlike Dr. Britto and Dr. Herman, Dr. Batzar is not an employee of 11
Glaxo. 12
Rather, Dr. Batzar spent most of his professional career with DuPont 13
and the focus of at least some of his research at DuPont involved 14
development of fluoropolymer coatings. Ex 2056, ¶ 2. 15
Dr. Batzar retired from DuPont in 1998 and formed his own 16
independent consulting company. Ex 2056, ¶ 2 and 5. 17
Ashurst offers Dr. Batzar as a coatings expert and does not suggest 18
Dr. Batzar has MDI experience. Paper 82, page 8:8-10. 19
According to Dr. Batzar, a "polymer specialist" would not have 20
expected a blend coating to resolve the problem of drug deposition in an 21
MDI. Ex 2056, ¶ 8:15-16. 22
Dr. Batzar based his opinion on knowledge and experience in the 23
industrial polymer coating industry and documents listed in his Curriculum 24
Vitae (Ex. 2057—which Dr. Batzar inadvertently refers to as Ex 2058 at 25
Ex 2056, ¶ 7:7 and ¶ 9:19-20). 26
30
Absent—one might say conspicuously absent—from the list of 1
documents are Canada 867 and the British patent specifications. 2
On the other hand, Dr. Batzar goes on to explain why during his time 3
with DuPont one would have expected in many situations that a blend 4
coating would be an improvement over a non-blend fluoropolymer coating. 5
Ex 2056, ¶ 11. 6
Like Dr. Britto, Dr. Batzar discusses stratification. 7
Dr. Batzar's stratification discussion is consistent with what one 8
skilled in the art would have learned from British 339 and British 851. 9
Insofar as Dr. Batzar was aware, prior to the 1993-1995 timeframe, a 10
fluoropolymer blend coating had never been used in an MDI. Ex 2056, ¶14. 11
The record would tend to support Dr. Batzar's awareness since the 12
first suggestion we know of to use a fluoropolymer as a coating appears in 13
Canada 867. Paper 82, page 5:24-6:2. 14
Dr. Batzar says use of a fluoropolymer blend coating in an MDI was a 15
"new and non-analogous application." 16
To the extent that use of any fluoropolymer in an MDI was "new," 17
Dr. Batzar does not say he was aware of Canada 867. 18
Dr. Batzar seems to say that the thickness of the MDI wall (it being 19
much thinner than other applications) "may have raised in the expert's mind 20
further impediments to achieving required levels of coating porosity and 21
stratification." Ex 2056, ¶ 18:7-10. 22
We note that Ashurst claims 23 does not contain a description of a 23
wall thickness limitation or any porosity requirement, but that Canada 867 24
describes wall thicknesses. Ex 2010, page 2, last ¶ ("approximately 0.1 mm 25
to approximately 2 mm). 26
Cross-examination of Dr. Batzar was not uneventful. 27
31
Numerous objections were made by counsel for Ashurst—many of 1
which were not justified and occurred right when something important was 2
asked, a tactic consistent with possible "witness coaching." 3
Interestingly, Dr. Batzar himself said at one point "I didn't hear an 4
objection." Ex 2082, page 46:13-14. 5
According to Dr. Batzar, fluoropolymer blend coatings were 6
developed in the 1970's to overcome adhesion problems. Ex 2082, 7
page 14:8-22. 8
Dr. Batzar's testimony is consistent with the publication dates of 9
British 339 (April 1971) and British 851 (Jan 1979). 10
Fluoropolymer blend coatings have become commercial because they 11
allow coatings to adhere to a substrate. Ex 2082, page 15:17-20. 12
Commercial practice is consistent with the blend coating improved 13
adhesion mentioned in British 339 and British 851. 14
Further according to Dr. Batzar, one must use a proper curing 15
temperature to be sure that you do not have fluoropolymer at the surface of 16
the substrate. Ex 2082, page 16:22 through page 17:5. 17
How would one know what temperature to use? Dr. Batzar tells us 18
that if a DuPont coating is used, "normally there is some sort of specification 19
sheet telling you how best to do this for each type of substrate." Ex 2082, 20
page 17:10-12. See also (1) Ex 2082, page 18:3-6, where Dr. Batzar adds 21
that you "have to put a lot of input into that to determine whether the coating 22
can actually be used" and (2) Ex 2082, page 42:16 through page 44:1. 23
Dr. Batzar's testimony is consistent with statements in the Ashurst 24
patent mentioning spray-coating "according to the vendor's standard 25
procedure." Ex 1004, Example 3, col. 7:36. 26
32
Dr. Batzar was asked which non-fluoropolymer might give best 1
performance. Ex 2082, page 24:18-19. 2
After an improper objection to the question (Ex 2082, page 24:20-21), 3
Dr. Batzar agreed that polyethersulfone is used in a variety of commercial 4
products including products in 1994. Ex 2082, page 25:16-20. 5
Dr. Batzar has no work experience with MDIs. Ex 2082, page 28:10. 6
He agreed that what he learned about MDIs came from the involved 7
Brugger application (which is equivalent to Canada 867) and the Ashurst 8
patents. Ex 2082, page 28:14-17. 9
According to Dr. Batzar, someone generally familiar with the coating 10
literature in mid-1990s would not have been aware of the benefits of 11
fluoropolymer blend coatings. Ex 2082, pages 32:22-33:3. 12
What about fluoropolymer coatings specifically? At this point there is 13
another inappropriate objection. Ex 2082, page 33:7-8. Dr. Batzar then 14
testified that he knows what folks at DuPont knew, but he could not be sure 15
what folks outside DuPont might have known. Ex 2082, pages 33:12-36:3. 16
We know on this record that a person having ordinary skill in the art is 17
charged with knowledge of what is described British 339 and British 851. 18
If Dr. Batzar is the expert he claims to be, having worked for a 19
corporation which is known for engaging in sophisticated research, we find 20
it hard to believe that Dr. Batzar would not have been aware of public blend 21
coating activities of others, e.g., Imperial Chemical Company as set out in its 22
fluoropolymer blend coating patents—one of which is British 851. 23
Dr. Batzar does confirm however, that "[w]e never used 24
fluoropolymers alone" because "[t]hey didn't adhere." Ex 2082, 25
page 37:15-19. 26
33
Common sense tells us that if fluoropolymers were not "adhering" for 1
DuPont, they would not have been adhering for other commercial entities in 2
the business of making a profit based on sale of products with fluoropolymer 3
coatings. 4
If fluoropolymers did not adhere, can it be said that Ashurst is now 5
telling us that use of fluoropolymers alone were "inoperative" or 6
"undesirable"? If so, we find it curious that the Ashurst claims cover an 7
MDI embodiment having just a fluoropolymer coating. See also Ex 1004, 8
col. 1:56-60, where Ashurst tells us—possibly contrary to Dr. Batzar—that 9
fluorocarbon polymers significantly reduce or essentially eliminate any drug 10
deposition problem. The fact that pre-litigation Ashurst claimed an MDI 11
embodiment with a fluoropolymer coating can be viewed as undermining 12
Ashurst's and Dr. Batzar's post-litigation position that some of the 13
embodiments within Ashurst's claims are perhaps undesirable from a 14
commercial point of view. We prefer to view the Ashurst position as one 15
where it maintains the use of blend coatings are an improvement over the 16
use of fluorocarbon polymer coatings. The British patents found, as did 17
Ashurst, that the use of blend coating are an improvement over the use of 18
fluorocarbon polymers. 19
In any event, some of Dr. Batzar's testimony is consistent with the 20
proposition that one skilled in the art would have substituted the blend 21
coatings of British 339 and British 851 for the fluoropolymers described in 22
Canada 867 to overcome known adherence problems. 23
Echoing Dr. Herman's testimony, Dr. Batzar says that in 1994 24
he would not have chosen to go with 100% fluoropolymer. Ex 2082, 25
page 50:3-5. 26
34
When asked whether his expectation would be that blend coating 1
might be better—followed by yet another inappropriate objection—2
Dr. Batzar stated that the blend coating probably would work better. 3
Ex 2082, page 51:10-19. 4
(4) Richard N. Dalby 5
Dr. Richard N. Dalby testified on behalf of Ashurst. Ex 2027. 6
Dr. Dalby is a Professor in the Department of Pharmaceutical 7
Sciences at the University of Maryland. Ex 2027, ¶ 1. 8
A primary focus of his work has been in development, evaluation and 9
product testing of MDIs. Ex 2027, ¶5. 10
Dr. Dalby attempts to define a person having ordinary skill in the art 11
in terms of education and years of experience. Ex 2027, ¶ 14. 12
While perhaps not irrelevant, education and years of experience 13
standing alone are not particularly helpful to the Board. Argyropoulos v. 14
Swarup, 56 USPQ2d 1795, 1807 (Bd. Pat. App. & Int. 2000). 15
Fortunately in this case, we have considerable prior art which itself 16
tells us what one skilled in the art would have known in 1995 when the 17
Canada 867 patent was published. 18
According to Dr. Dalby the challenge to find a suitable coating for an 19
MDI "ended up being a long, uphill struggle." Ex 2027, ¶ 20:11-12. 20
It appears that much of that struggle took place before publication of 21
Canada 867. 22
One struggle was active ingredient sticking to the wall of the MDI. 23
As Dr. Dalby saw it, "in most cases, no amount of manual shaking 24
could re-disperse [the drug stuck to MDI wall back] into the formulation." 25
Ex 2027, ¶ 24:10-11. 26
35
Another struggle is said to have been surfactants not dissolving in the 1
fluorocarbon. Ex 2027, page 7, ¶ 25. 2
One wonders what the discussion about surfactants is all about when 3
Ashurst claim 23 does not require a surfactant and the Ashurst specification 4
talks in terms of surfactants "optionally" being present. Ex 1004, col. 2:35 5
and 44. 6
We also note that in Example 3 involving a PTFE-PES coating blend 7
no mention is made of a surfactant. 8
Dr. Dalby takes us through the efforts to solve the "problem" after 9
the switch from chlorofluorocarbons to fluorocarbons. Ex 2027, ¶ 27. 10
Much of the Ashurst effort seems to pre-date the publication of 11
Canada 867. 12
With respect to all the uncertainties Dr. Dalby proffers, nowhere is 13
there an explanation why Canada 867 does not go a long way to suggests 14
that the uncertainties are not so uncertain. 15
Dr. Dalby understands that Glaxo conducted experiments which were 16
said to show that blend coatings improved overall performance. 17
Dr. Dalby bottoms his belief on the contents of Ex 2058. Ex 2027, 18
¶ 37. 19
Ex 2058 appears to be a report on the status of an MDI can coating 20
program for 134a products. 21
Describing what Glaxo refers to as an SUT test, Ex 2058 purports to 22
say that some testing will take place during the week of July 31, presumably 23
of 1995. 24
Dr. Dalby does not purport to say that he had anything to do with the 25
Glaxo testing program. 26
We deal later with Brugger's objection to the admissibility of Ex 2058. 27
36
What becomes apparent, even if we accept Dr. Dalby's analysis of 1
Ex 2058, is that testing took place soon after publication of Canada 867. 2
Testing would have been entirely appropriate given what one skilled 3
in the art would have learned from British 339 and British 851. 4
Thus, one view—and the most likely view—of the evidence is that 5
Glaxo scientists were doing exactly what the prior art suggested even if they 6
may not have known about the prior art. 7
One reason Dr. Dalby's testimony gives us pause is that apart from a 8
brief reference to Canada 867 and other prior art relied upon by Brugger, the 9
Dalby testimony does not contain any extensive, let alone convincing, 10
discussion of the prior art which appears in this record. 11
(5) Dave R. Elder 12
Dave R. Elder testified on behalf of Ashurst. Ex 2059. 13
Mr. Elder gives an account of Glaxo sales of MDI products approved 14
by the FDA which incorporate at least one particulate drug and a 15
hydrofluoroalkanes propellant such as Propellant 134A or Propellant 227. 16
Ex 2059, page 2, ¶ 2:7-11. 17
According to Mr. Elder, Glaxo has three FDA approved products on 18
the market: 19
(1) VENTOLIN HFA® (albuterol sulfate), 20
(2) FLOVENT HFA® (fluticasone propionate), and 21
(3) ADVAIR HFA® (fluticasone propionate and salmeterol 22
xinafoate). Ex 2059, page 3, ¶ 4. 23
Further according to Mr. Elder, the inner surface of each product is 24
coated with a blend of polytetrafluoroethylene (PTFE) and polyethersulfone 25
(PES). Ex 2059, page 2, ¶ 3. 26
37
Nowhere, however, does Mr. Elder identify the precise nature of the 1
PTFE, the PES or the amount of each. 2
Particularly critical would be the nature of the PES. 3
British 851 reveals that differences in the PES can have an effect on 4
the properties of any PTFE/PES blend coating. 5
No one can deny that Glaxo has sold FDA approved MDI's. Ex 2059, 6
page 4, ¶ 6. 7
We have no idea what the competition, total market, Glaxo's market 8
share, Glaxo's advertising budget, etc., might have been, but will note that 9
the Ashurst patents might have given others pause about entering the market 10
with Glaxo-like products. 11
In any event, we find that the products which Mr. Elder says were 12
sold have not been shown to be commensurate in scope with the alternatives 13
which fall within the scope of Ashurst claim 23. 14
(6) Dilraj Singh 15
Dr. Dilraj Singh testified on behalf of Brugger. Ex 1007, Ex 1088 and 16
Ex 1086. 17
Dr. Singh is an employee of Novartis Pharma AG in Switzerland. 18
Ex 1007, ¶ (2). 19
In 1994, Dr. Singh was awarded a Ph.D. from the School of Pharmacy 20
of the University of Bradford in the UK. Ex 1007, ¶ (8). 21
Dr. Singh is familiar with preformulation and formulation science and 22
in-vitro testing of inhalation devices and formulations. Ex 1007, ¶ (7). See 23
also Ex 1006, page 1: "I am a pharmaceutical scientist with 12 years… 24
experience in preformulation, formulation and analytical development of 25
inhalation dosage forms." 26
38
Dr. Singh is of the view that an important commercial use of MDIs is 1
in the treatment of respiratory disorders. Ex 1007, ¶ (16). 2
Dr. Singh confirms that in the August 1994 timeframe (Ex 1007, 3
¶ (17)), beclomethasone dipropionate was used in aerosol compositions and 4
in inhaler formulations. Ex 1007, ¶ (200) and (203). 5
In view of the well-known use, Dr. Singh believes that it would have 6
been "routine"—to use Dr. Singh's words—for a person having ordinary 7
skill to use beclomethasone dipropionate in the device of claim 9 of Brugger. 8
Ex 1007, ¶ (208). 9
Dr. Singh did not purport to testify on adherence of polymers or 10
plastic coatings to an inner surface of an MDI. 11
(7) Vijay Gupta 12
Dr. Vijay Gupta testified on behalf of Brugger. Ex 1088 and Ex 1089. 13
Dr. Gupta is a professor at UCLA in Los Angeles, California. 14
Ex 1088, ¶ (2). 15
Among other things, Dr. Gupta has had experience in the area of 16
surface and interface science with a focus on design, characterization and 17
manufacturing of surface and interfacial variable for polymers on various 18
engineering substrates. Ex 1088, ¶ (8). 19
In Dr. Gupta's opinion, a person having ordinary skill in the art before 20
us would have been familiar with formulation issues relating to active 21
ingredients and with the design and fabrication of MDIs. Ex 1088, ¶ (28). 22
A person skilled in the art would have also been familiar with 23
literature related to coating technology. Id. 24
While Dr. Gupta did not find any explicit discussion of adhesion of 25
coating to MDI walls in the Brugger application, in his view one skilled in 26
the art would have appreciated that the coating must have an acceptable 27
39
level of adhesion to the wall otherwise it could separate with adverse 1
consequences to safety of the user of the MDI. Ex 1088, ¶ (38). 2
Dr. Gupta was concerned with the fact that the MDI surface is 3
aluminum metal. Ex 1088, ¶ (39). 4
Dr. Gupta, assessing the entire disclosure of the Brugger application, 5
notes that it describes the use of a "plastic coating" and that a plastic coating 6
is a generic term that includes a variety of different polymer materials. 7
Ex 1088, ¶ (34). 8
Dr. Gupta agrees with Ashurst witnesses that, in 1994 prior to the 9
Brugger application and the Ashurst patents, one skilled in the art would not 10
have been able to predict that coatings composed solely of a fluorocarbon 11
polymer would solve the problem of drug deposition on the inner wall of 12
MDIs. 13
Based on Dr. Gupta's testimony, we are able to make several findings. 14
According to Dr. Gupta, one skilled in the art would have been 15
"motivated"—to use Dr. Gupta's words—to use a blend per claim 23 of 16
Ashurst because the count includes use of either a fluorocarbon polymer or 17
a mixture of a fluorocarbon polymer and a non-fluorocarbon polymer. 18
Ex 1088, ¶¶ (121)-(122). 19
We decline to credit this limited portion of Dr. Gupta's testimony 20
because it appears Dr. Gupta may have been operating on an incorrect 21
analysis of what should be considered prior art. 22
While it is true that the general rule is that the entire scope of the 23
count is normally presumed to be prior art, in a case like this where the 24
scope of the count and claim correspondence are simultaneously in issue, the 25
general rule does not necessarily apply or may make sense. Why? In this 26
case, Ashurst maintains that embodiments made with a fluorocarbon 27
40
polymer coating and a mixture of a fluorocarbon polymers and non-1
fluorocarbon polymer are patentably distinct. If the count is narrowed to 2
exclude the blend coatings, then the count would not include the subject 3
matter on which Dr. Gupta was told—apparently by counsel—to include in 4
his analysis. Only Ashurst describes and claims the use of mixtures. If the 5
count is narrowed to exclude mixtures, then use of mixture in the former 6
count amounts to use of Ashurst's own invention against Ashurst. Such a 7
use does not make sense and is neither right nor fair. Cf. Riverwood Int'l 8
Corp. v. R. A. Jones & Co., 324 F.3d 1346, 1355 (Fed. Cir. 2003) (inventor's 9
own work cannot be used as prior art against the inventor). 10
While we decline to credit the above-discussed limited portion of 11
Dr. Gupta's testimony, we otherwise find the testimony credible. 12
One difference which stands out when Dr. Gupta's testimony is 13
compared to the Ashurst witnesses, including Dr. Batzar's testimony, is that 14
Dr. Gupta refers to, and discusses, the prior art, including the British patent 15
specifications and Dr. Batzar's journal article. When the testimony of a 16
witness is supported by references to the prior art, the testimony becomes 17
credible vis-à-vis the testimony of a witness who does not back up opinions 18
by reference to the prior art. Unsupported testimony of experts need not be 19
credited. Rohm and Haas Co. v. Brotech Corp., 127 F.3d 1089, 1092 (Fed. 20
Cir. 1997) (nothing in the Federal Rules of Evidence or Federal Circuit 21
jurisprudence requires the fact finder to credit the unsupported assertions of 22
an expert witness). 23
Dr. Gupta does not limit his analysis to that part of the count which 24
calls for use of mixtures and presents a factual discussion assuming that the 25
count does not explicitly recite mixtures including non-fluorocarbon 26
polymers. Ex 1088, ¶ (123). 27
41
Dr. Gupta tells us, and the prior art confirms, that fluorocarbon 1
polymer coating have non-stick properties. Ex 1088, ¶ (124). 2
Dr. Gupta further tells us, and the prior art confirms, that "pure 3
fluorocarbon polymer coatings" have low toughness and durability. 4
Ex 1008, ¶(126); Ex 1043, page 1:16-24. 5
Dr. Gupta still further tells us, and the prior art confirms, that blends 6
of fluorocarbon polymers and non-fluorocarbon polymers were known and 7
were recognized as solving problems associated with adherence of a 8
fluorocarbon polymer to a metal surface. Ex 1088, ¶¶ (130)-(131). 9
In support of his views, Dr. Gupta calls attention to Batzar, Principles 10
of Adhesion of Fluoropolymer Coatings to Substrates, 13 Adv. Org. Coating 11
Sci. Tech. Service 463, 467 (1991). Ex 1036. "Batzar" is Dr. Batzar who 12
testified on behalf of Ashurst. Paper 77, page 15:2-3. 13
Beginning in the 2d full paragraph on page 467, there is a discussion 14
of why stratification is significant and how one might go about determining 15
a proper ratio of polymers and curing temperature. Ex 1036, pages 467 et 16
seq. 17
Discussion 18
(1) 19
The scope of a count defines the scope of the admissible evidence on 20
the issue of priority. 37 C.F.R. § 41.201 (definition of count) (2007). See 21
also Squires v. Corbett, 560 F.2d 424, 433 (CCPA 1977), now codified in 22
§ 41.201. 23
(2) 24
A count should define a single patentable invention. 25
42
If a count includes within its scope two patentably distinct inventions, 1
say invention A and invention B, then priority proof of either invention A or 2
invention B would defeat the opponent's right to both A and B. 3
That is not right or fair. Godtfredsen v. Banner, 598 F.2d 589, 592 4
(CCPA 1979) ("Where, as here, the parties both disclose the same three 5
species, that fact does not justify including those species in a single count as 6
members of a Markush group if the Examiner has determined that the three 7
species are patentably distinct inventions. If such a count were permitted, 8
then the party who proved the earliest date of invention as to any one of the 9
members of the group would be awarded priority as to the entire count, i.e., 10
as to all three members. It is not considered that such a result would be 11
consonant with the primary purpose of an interference or with the intent of 12
35 U.S.C. 135, since there would be no determination of priority as to each 13
of the common [patentably distinct] inventions claimed by the parties 14
[emphasis in original]."). 15
(3) 16
In this case, both parties claim a first embodiment comprising an MDI 17
with a fluorocarbon polymer coating. 18
Ashurst, but not Brugger, also claims a second embodiment of an 19
MDI coated with a "blend coating" of a fluorocarbon polymer and a non-20
fluorocarbon polymer. 21
Count 1—the count of the interference as declared—covers both the 22
first and second embodiments. 23
Ashurst says that the second embodiment is patentably distinct from 24
the first embodiment and therefore a count should be substituted for Count 1 25
which is limited in scope to the first embodiment. 26
(4) 27
43
Once a count is determined, then a review is made of the claims of the 1
parties to see whether some or all of those claims should be designated as 2
corresponding to the count. 3
A claim which is designated as corresponding to the count must be 4
unpatentable over the subject matter of the count—the count alone or in 5
combination with other prior art. 6
A claim which is designated as not corresponding to the count has to 7
be patentable over the subject matter of the count. 8
Because Ashurst maintains that the subject matter of Ashurst claim 23 9
is patentable over Proposed Count A, Ashurst moves to have claim 23 10
designated as not corresponding to any new count. 11
As will become apparent it does not matter in this case whether the 12
count is Count 1, Count A or Count B. 13
To determine whether a new count should be substituted, we would 14
need to evaluate whether the first and second Ashurst embodiments are 15
directed to the same patentable invention, i.e.: Is the second embodiment 16
patentable over the first embodiment? 17
If so, a new count (e.g., Count B) would be in order. 18
Assuming that a new count is proper, we would then need to 19
determine whether Ashurst claim 23 is patentable over the new count. 20
But, as it turns out in this case, resolution of whether there should be a 21
new count and whether Ashurst claim 23 should correspond to the new 22
count involves resolution of very similar, if not identical, issues. 23
(5) 24
The nature of a count in an interference is dependent on the facts in 25
each case. 26
44
There is much to be said about having a count define common subject 1
matter. However, having a count define common subject matter is easier 2
said than done. Parties present claims of different scope and wording based 3
on different specifications. Often there is considerable overlap. More often 4
than not, the scope of the claims differs in one fashion or another. 5
The count limits the scope of the priority proofs, whether the claims 6
are common or not. 7
There have been cases where there is no common subject matter. See, 8
e.g., Aelony v. Arni, 547 F.2d 566 (CCPA 1977) (a case where the claims of 9
the parties did not overlap at all, yet there was an interference). 10
We do not have an Aelony v. Arni case before us. 11
Common to both Ashurst and Brugger is an MDI coated with only a 12
fluorocarbon polymer albeit the "common" aspect of the Ashurst and 13
Brugger inventions are not worded in an identical manner. 14
Brugger alleges that Count 1 should remain, citing and relying on 15
Heymes v. Takaya, 6 USPQ2d 1448, 1450 (Bd. Pat. App. & Int. 1998). 16
Paper 48, pages 19-20. 17
Apart from the fact that the rules associated with counts have changed 18
since Heymes, the then reason for permitting broad counts was to permit 19
more proofs. 20
Godtfredsen v. Banner, which, unlike Heymes, is binding precedent 21
shows why the Heymes rule is not a broad as Brugger would wish. 22
Additionally, since no priority proofs are to be offered, Brugger 23
should not be concerned with the scope of the count as long as Ashurst 24
claim 23 is designated as corresponding to the ultimate count. 25
There is another unusual fact in this case and that is Canada 867—26
which is essentially identical to the specification of the involved Brugger 27
45
application—is prior art. Accordingly, we are not limited to the subject 1
matter of the count as we would be in other interferences which come before 2
us. In effect, Brugger can rely on all of the disclosure of Canada 867. 3
Since it does not seem to matter, and while it may not satisfy all, we 4
elect to (1) substitute our own Count B for Count 1 (because it is clearer than 5
Ashurst's Count A which includes alternative limitations) and (2) resolve the 6
interference by deciding whether Ashurst claim 23 is unpatentable over the 7
subject matter of Count B and other available prior art. 8
Our Count B reads: 9
A metered dose inhaler having part or all of its internal surfaces 10
coated with only one or more fluorocarbon polymers for 11
dispersing an inhalation drug formulation, comprising a 12
particulate drug and a fluorocarbon propellant. 13
We have included the word "only" at the suggestion of Ashurst. 14
Paper 77, page 3:9. 15
Essentially, the issue becomes is Ashurst claim 23 patentable over 16
(1) the subject matter of Count B or Canada 867 and (2) the other prior art 17
discussed above. 18
We conclude that it is not and will (1) deny Ashurst's motion as to 19
claim 23, (2) grant Brugger Substitute Motion 1 as to claim 23, and 20
(3) designate Ashurst claim 23 as corresponding to Count B. 21
We would reach the same result even if the count were original 22
Count 1 or Ashurst's proposed Count A. 23
(6) 24
As noted earlier, there are two differences between Ashurst claim 23 25
and Canada 867. 26
46
One difference is that Ashurst claim 23 calls for the MDI having the 1
active ingredient beclomethasone dipropionate. 2
But, the prior art reveals that it was known to use an MDI to 3
administer beclomethasone dipropionate. 4
To borrow language from a recent Federal Circuit opinion, this 5
difference represents" a textbook case of when the asserted claims involve a 6
combination of familiar elements according to known methods that does no 7
more than yield predictable results." Agrizap, Inc. v. Woodstream 8
Corporation, 520 F.3d 1337, 1344 (Fed Cir. 2008), citing KSR International 9
Co. v. Teleflex Inc., 127 S. Ct. 1727, 1739 (2007). See also Anderson's-10
Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57 (1969). 11
Another difference is Ashurst's use of blend coatings in place of a 12
fluoropolymer coating. 13
Once Canada 867 was published, the use of polytetrafluoroethylene as 14
a coating on the inside of an MDI entered the public domain. 15
While Ashurst seems to maintain otherwise, the evidence before us as 16
a whole supports a finding that those skilled in the art knew that polytetra-17
fluoroethylene had adhesion problems. 18
Already in the public domain, but for other uses, were blend coatings 19
comprising a fluorocarbon polymer and a non-fluorocarbon polymer, 20
including (1) polyamides, (2) polyimides, (3) polyamideimides, 21
(4) polyethersulphones, and (5) amine-formaldehyde resins. 22
Still further in the public domain was knowledge that blend coatings 23
had better adhesion characteristics. 24
Both coatings made polytetrafluoroethylene and blend coatings made 25
from fluorocarbon polymers and a non-fluorocarbon polymer were known. 26
47
Both served to coat surfaces, including aluminum surfaces, where 1
adherence to the surface and non-stick properties were desirable. 2
Ashurst, like the prior art, tells us that use of the non-fluorocarbon 3
polymer add "improve adhesion of the polymer coating to the can walls." 4
Ex 1004, col. 4:39-40. 5
Unfortunately for Ashurst, the British patent specifications tell us, and 6
more importantly told one having ordinary skill in the coating art as of 1995, 7
exactly the same thing. 8
Ashurst claim 23 involves a combination of old elements being used 9
precisely for the intended purpose to achieve a predictable result. 10
(7) 11
Ashurst makes several points opposing a holding of obviousness. 12
(a) 13
According to Ashurst, the "blend coatings" are a commercial success. 14
Paper 51, page 5:3-13. 15
More to the point is that MDIs having a blend coating of (1) a 16
particular but unidentified polytetrafluoroethylene and (2) a particular, but 17
unidentified, polyethersulfone may be a Glaxo commercial embodiment. 18
Unfortunately for Ashurst, claim 23 is not limited to a 19
polyethersulfone non-fluorocarbon polymer and therefore, Ashurst's 20
commercial success argument is foreclosed by In re Tiffin, 58 CCPA 1420, 21
448 F.2d 791 (CCPA 1971). 22
Even if we assume arguendo that a blend coating of 23
polytetrafluoroethylene and polyethersulfone was a commercial success, 24
Ashurst claim 23 covers a variety of non-fluorocarbon polymers, most of 25
which Ashurst does not claim are commercially successful—perhaps 26
48
because most have never been the subject of an FDA approval and perhaps 1
cannot be commercially marketed. 2
(b) 3
Ashurst next maintains that the MDIs of claim 23 possess unexpected 4
properties. 5
Clear and convincing evidence is necessary to support an allegation of 6
unexpected properties. McClain v. Ortmayer, 141 U.S. 419, 429 (1891) 7
(conclusive evidence needed to establish new function); In re Heyna, 53 8
CCPA 1331, 1337, 360 F.2d 222, 228 (CCPA 1966) ("It was incumbent 9
upon appellants to submit clear and convincing evidence to support their 10
allegation of unexpected property."); In re Passal, 57 CCPA 1260, 1264, 11
426 F.2d 409, 412 (CCPA 1970); and In re Lohr, 50 CCPA 1274, 1279, 317 12
F.2d 388, 392 (CCPA 1963). 13
Ashurst has failed to carry its evidentiary burden, even under a 14
preponderance of the evidence standard. First, we do not know who 15
conducted the tests—Dr. Britto or someone else at Glaxo. Second, Ashurst 16
recognizes that Canada 867 is the closest prior art. Paper 77, page 8:4-5. 17
Canada 867's preferred "prior art" polytetrafluoroethylene does not seem to 18
have been tested. Thus, the closest prior art was not tested. In re Baxter 19
Travenol Lab., 952 F.2d 388, 392 (Fed. Cir. 1991) (when unexpected results 20
are used as evidence of nonobviousness, the results must be shown to be 21
unexpected compared with the closest prior art) [citation omitted]. Third, as 22
in the case of commercial success, a showing of unexpected results must be 23
commensurate in scope with the breath of the claim. In re Greenfield, 24
571 F.2d 1185, 1189 (CCPA 1978) (showing of unexpected results must be 25
commensurate in scope with breadth of claim) [citation omitted]; see also In 26
re Kulling, 897 F.2d 1147, 1149 (Fed. Cir. 1990); In re Lintner, 457 F.2d 27
49
506, 508 (CCPA 1972). Numerous non-fluoropolymer embodiments falling 1
within the scope of the Markush group (ii) of Ashurst claim 23 have not 2
been shown to have been tested. Fourth, to the extent that non-3
fluoropolymers were tested and were shown to achieve "better" properties, 4
British 339 and British 851 establish that "better" adherence would have 5
been expected. 6
A significant prior art document is Canada 867. 7
Once it was published, it appears that development of better MDIs 8
proceeded in a rather straightforward manner. 9
When personnel at Glaxo were actually became aware of Canada 867 10
and the British patent specifications is irrelevant. In re Kleinman, 484 F.2d 11
1389, 1392 (CCPA 1973) (there is no presumption that the holder of a patent 12
[in this case Ashurst] had actual knowledge of the prior art when the 13
invention was made—hypothetical person skilled in art has constructive 14
knowledge of relevant prior art). 15
Dr. Batzar's belief that "this is a new and non-analogous application" 16
is in large measure answered by Canada 867. 17
The prior art leads one skilled in the art right down the same path 18
taken by Glaxo and tells one skilled in the art how to solve the adherence 19
problem. 20
Dr. Batzar seems to be saying that one skilled in the art could not be 21
reasonably sure whether any particular blend coating would "succeed" in 22
solving the drug deposition problem, absent testing and evaluation. 23
Ex 2056, ¶ 19. 24
Given the disclosure of British 339 and British 851, which Dr. Batzar 25
did not discuss, we have difficulty agreeing with Dr. Batzar's views—at least 26
50
to the extent that he insinuates sub silencio that "undue" experimentation 1
would have been necessary. 2
Beyond that, to the extent Glaxo was using DuPont PES, Dr. Batzar 3
told us that DuPont products were accompanied by an instruction sheet, a 4
fact confirmed in the Ashurst patent itself. 5
Lastly, we note that Dr. Batzar testified that a "correct range of high 6
temperature curing induces" proper stratification. Ex 2056, page 3, 7
¶ 11:17-20. See also Ex 2082, page 16:20 through page 18:6. 8
How one skilled in the art would have determined a correct 9
temperature range without some experimentation escapes us, particularly 10
when it comes to a "commercial" embodiment. 11
In this sophisticated art, testing would appear to be the norm—not the 12
exception. See, e.g., Ex 1036, page 467 et seq. discussing, inter alia, 13
stratification and describing tests to achieve proper PTFE/PES polymer 14
ratios and curing temperatures. 15
Determining the appropriate temperature is exactly what one skilled in 16
the art could, and would, have done in this art. 17
(c) 18
Each party has presented testimony of "expert" and fact witnesses. 19
Each party has a lot of negative things to say about the other party's 20
witnesses. 21
However, for reasons already given, and while we cannot credit some 22
of the testimony, we find generally that the testimony assisted us in 23
understanding the background surrounding the making of the invention 24
before us. 25
We find, except as noted, that Dr. Gupta's testimony is credible and 26
we give it considerable weight. 27
51
We also find, to the extent that it is relevant, Dr. Singh's testimony to 1
helpful. 2
Both Dr. Gupta and Dr. Singh refer to prior art to support their 3
positions. 4
Ashurst says that Dr. Gupta does not have experience with 5
pharmaceuticals and that Dr. Singh does not have experience with the 6
physical aspects of MDIs. 7
Accordingly, Ashurst suggests that neither can tell us about the level 8
of skill in the art because someone skilled in the art has to be skilled in 9
pharmaceuticals and physical aspects of MDI. 10
Both arts are involved in this case. 11
Accordingly, the hypothetical person skill in the art is charged with 12
knowledge of both arts. 13
Dr. Singh did not purport to say whether blend coatings would have 14
been substituted for fluorocarbon polymers. He confined his testimony to 15
things about which he has experience. 16
The same is true for Dr. Gupta. Moreover, we note that Dr. Gupta 17
referred extensively to the prior art in rendering his testimony. 18
Dr. Britto, Dr. Herman and Mr. Elder, all employees of 19
GlaxoSmithKlein provided information concerning why the invention was 20
necessary and how it came to be. 21
One problem with their testimony is that it discusses numerous events 22
which took place before Canada 867 was published—probably in the 23
confines of research facilities not open to the public. However, in our view, 24
the issue date of Canada 867 is an appropriate starting point for the 25
obviousness analysis. In other words: As of the date of the publication of 26
Canada 867, what would one skilled in the art found to have been obvious? 27
52
Dr. Batzar's testimony also suffers from a pre-Canada 867 publication 1
deficiency. Moreover, his apparent inability to say what was going on 2
outside DuPont gives us pause. The ICI British patent applications were in 3
the public domain. We have been influenced-in-part in our credibility 4
assessments with numerous improper objections made by counsel for 5
Ashurst at points in the testimony where critical questions were answered. 6
Any doubt we have on this matter we resolve against the Batzar testimony 7
because the Ashurst objections have every appearance of being, and may 8
have been, witness coaching. As we noted before, Dr. Batzar noted the 9
absence of an objection at one point—a comment we find curious when 10
made by a witness. 11
Some witnesses are employed by the real parties in interest. 12
Employment was not a factor in our credibility assessment. Apart from the 13
possible witness coaching of Dr. Batzar, it is our view that each witness 14
testified in a truthful manner consistent with their beliefs and experience. 15
The fact that some of the witnesses are employed by the real parties in 16
interest has not been any concern to us in this case. 17
Additional briefs 18
1. Brugger additional brief on issue 1 19
Brugger maintains that Count B (or Count A for that matter) should 20
not be substituted for Count 1 because Brugger describes the use of 21
"plastics" broadly. Paper 68. 22
A description of "plastics" is not a description of the Markush group 23
of non-fluoropolymers described and claimed by Ashurst. 24
While it is true that a description of "plastics" in Canada 867 suggests 25
that polymers beyond the fluoropolymers may be used, it takes other prior 26
art (e.g., the British patent specifications and other prior art mentioned (a) by 27
53
the parties and (b) in this opinion) to assess the "obviousness" of using a 1
blend coating vis-à-vis a polytetrafluoroethylene. 2
The principal issue is whether use of blend coatings would have been 3
obvious under 35 U.S.C. § 103 over the use of polytetrafluoroethylene when 4
the prior art, as a whole, is considered. 5
Accordingly, Count B is the more appropriate count in these 6
interferences. 7
2. Ashurst additional brief 8
While there may be some overlap with observations made earlier in 9
this opinion, we add the following to address argument made by Ashurst in 10
its additional brief (Paper 77). 11
(1) 12
Ashurst says (Paper 77, page 8:7-13): 13
The record does not establish that the inner wall of an MDI 14
needed protection from an inhalable aerosol formulation 15
comprising HFC 134a or 227, which can cause cracks and 16
pinholes in the coating. The record does not establish that HFA 17
inhalable formulations damage the inner wall of an MDI. The 18
problem recognized by the prior art concerning HFA inhalable 19
formulations was drug deposition, not degradation or 20
delamination of the coating. 21
We find nothing in the Ashurst patent involved in this interference, or 22
the Britto patent and Ashurst patents involved in Interferences 105,424 23
through 105,626, which discusses, or shows that Ashurst or Britto were 24
aware of, "cracks" or "pinholes" in coatings or that propellants would 25
damage the inner wall of an MDI. See also Paper 82, page 25:6-8. 26
To the extent that Ashurst now relies on these factors in support of its 27
54
non-obviousness argument, we find that these factors are a post-litigation 1
"afterthought." Cf. (1) Graham v. John Deere Co., 383 U.S. 1, 24-25 (1966) 2
(free-flex function characterized as an "afterthought") and (2) Lincoln 3
Engineering Co. of Illinois v. Stewart-Warner Corp., 303 U.S. 545, 550 4
(1938) (patentee's suggestion with respect to the function of a nipple seems 5
to be an afterthought, no such function was hinted at in the specification) 6
and compare United States v. Adams, 383 U.S. 39, 49 (1966) (Adams' 7
reliance on water-activated feature, having been disclosed in the 8
specification, "was not the afterthought of as astute patent trial lawyer."). 9
On this record what is manifest is that had "cracks", "pinholes" and 10
damage to the inner walls been a problem, their solution is manifest. Canada 11
867 shows why a polytetrafluoroethylene coating would protect the inner 12
wall of the MDI and the British patent specifications reveal that a blend 13
coating would adhere to the wall better than a polytetrafluoroethylene 14
coating. 15
(2) 16
According to Ashurst (Paper 77, page 8:22 through page 9:1: 17
In order to demonstrate that an invention is [would have 18
been] obvious, there must be an apparent reason to make a 19
change, which can be driven by express teachings in the prior 20
art or a "design need or market pressure to solve a problem." 21
[citation omitted] 22
Here we have both. Elimination of drug deposition on the inside wall 23
of an MDI was an industry concern, as well perhaps as an FDA concern. 24
Accordingly, there was market pressure to solve drug deposition. The prior 25
art reveals that if the inner wall of the MDI is coated with polytetrafluoro-26
ethylene drug deposition is not as much of a problem. To the extent that use 27
55
of a polytetrafluoroethylene coating alone raised adherence concerns, the 1
prior art also tells on skilled in the art that use of certain blends, all described 2
in the British patent specifications, improves adherence. 3
(3) 4
Ashurst says that Brugger's witness, Dr. Gupta, testified that the 5
coating adhesion described in Canada 867 was sufficient for Brugger's MDI 6
application and therefore there would be no need for further research or 7
investigation because there was no problem to be solved. Paper 77, 8
page 9:3-21; Paper 82, page 15:3-5. 9
Ashurst is in a poor position to make these arguments. Contrary to 10
Ashurst's argument, there was a recognized adherence problem. The record 11
contains convincing prior art and testimony which reveals that those skilled 12
in the art recognized that polytetrafluoroethylene might not adhere to 13
surfaces as well as might be desired. See e.g., (1) British 339, Ex 2048, page 14
1:14-24 and (2) Dereich, U.S. Patent 3,194,428, Ex 1039, col. 2:37-40. The 15
British patent specifications provide the solution to a problem which we feel 16
was recognized in the art The fact that Ashurst was concentrating on MDIs, 17
whereas the prior art was concentrating on adherence problems associated 18
with other uses of blend coatings, does not render irrelevant the prior art. 19
The problem was an adherence problem. The British patent specifications 20
provide the answer to the problem. "Common sense teaches … that familiar 21
items [e.g., blend coatings with better adherence on various metals] may 22
have obvious uses beyond their primary purposes and in many cases [such as 23
this case] a person of ordinary skill will be able to fit the teachings of 24
multiple patents [e.g., Canada 867 and the British patent specifications] 25
together like pieces of a puzzle." KSR, 127 S. Ct. at 1742. An example of 26
the "obvious uses" referred to in KSR is the mechanical closure problems 27
56
addressed in Graham v. John Deere Co., 383 U.S. 1, 35 (1966), involving 1
the Scoggin patent. The problem here is adherence. The prior art, like that 2
in Graham, provides the solution. 3
(4) 4
Ashurst argues (Paper 77, page 10:10-12): 5
If a "problem" with fluorocarbon polymers in the MDI context 6
was not recognized (which it had not been), a solution to the 7
unrecognized problem could not have been prima facie 8
obvious. 9
Ashurst's argument a re-packaged version of similar arguments made 10
throughout the case and repeated at oral argument. Paper 82, page 15:3-5. 11
The difficulty with Ashurst's argument is that the very problem encountered 12
by those skilled in the art in the MDI field had been encountered in other 13
fields using the same coatings which were being considered in the MDI 14
field. As we said earlier, the problem appears to have been a known 15
adherence problem to which the prior art provides a known solution. At the 16
end of the day, Ashurst used known techniques with known blend coatings 17
to solve a known problem all the while not achieving any unexpected or 18
unpredictable results. 19
But, Ashurst says that cookware presents unique problems, including 20
scraping (e.g., to clean a frying pan) and high temperature use (e.g., frying 21
something in a frying pan). Transcript of Oral Argument, Paper 82, 22
page 19:1-23. Overlooked by Ashurst and its witnesses is the suggestion in 23
British 851 that its blend coatings may be used in a wide variety of 24
applications. Ex 2026, page 4:106 through page 5:38. The apparent attempt 25
by Ashurst to pigeon-hole the use described in the British patents to 26
57
cookware is inconsistent with the use actually described by the British 1
patents—including such items as "ice separators" (page 4:130 to page 5:1) 2
(5) 3
According to Ashurst there was a "negative motivation" to add a "high 4
surface energy" non-fluorocarbon polymer to a fluorocarbon polymer. 5
Ashurst reasons that a person having ordinary skill in the art would have 6
believed "this" would make the coating less "non-stick" thus leading away 7
from the "blend invention". Paper 77, page 10:14-18. 8
We find this argument completely answered by the British patent 9
specifications which reveal exactly the opposite of what Ashurst contends. 10
The prior art teaches that blend coatings "stick" better than polyfluoro-11
ethylene polymers. To the extent that scientists at Glaxo felt that "high 12
surface energy" was an issue, they apparently were not aware of the British 13
patent specifications. 14
Ashurst goes on to say "[t]he consensus is that persons of ordinary 15
skill, and experts alike, would have expected the non-fluorinated polymers 16
to have poorer drug deposition properties than a pure fluoropolymer." 17
Paper 77, page 10:20 through page 11:1. 18
The British patent specifications explain how the blend is "stratified." 19
Stratification results in the fluoropolymer being on the drug contact side and 20
the non-fluoropolymer adhering to the inside aluminum surface of the MDI. 21
The post-litigation "consensus" suggested by Ashurst does not square with 22
the more convincing pre-litigation "consensus" manifest in the British patent 23
specifications. Cf. In re Carroll, 601 F.2d 1184, 1186 (CCPA 1979) (a 24
witness is permitted, however, to testify on what the prior art teaches; 25
("[u]nlike the usual expert opinion, prepared either by the applicant himself, 26
or on his behalf after the controversy has arisen, Dr. Merkal's opinion was 27
58
formulated prior to the making of the claimed invention. It was therefore 1
completely untainted by either hindsight or bias."). 2
(6) 3
Another negative-motivation argument presented by Ashurst is the 4
following. Paper 77, page 11:8-11 [citations omitted]): 5
Another “negative motivation” for using a blend is that 6
high temperature curing of polymer blends is necessary, and 7
this could produce undesirable degradation products and 8
technical problems with the integrity of the MDI cans. 9
According to Ashurst, curing temperatures of the preferred blends is 10
accomplished at 300º C. to 400º C. Ex 1004, col. 6:24-31. The blends may 11
be cured on aluminum substrates. Ex 1004, col. 5:60. 12
British 851 describes polytetrafluoro-ethylene and polyethersulphone 13
blends cured on aluminum at temperatures of preferably above 350º C, 14
particularly between 380º C to 400º C. Ex 2026, page 4:73-77 and 112 15
(aluminum). 16
The British 851 tells those skilled in the art to use the higher range of 17
the temperature described by Ashurst. 18
Moreover, Canada 867 teaches that polytetrafluoroethylene is coated 19
on the MDI can wall in a variety of ways. Ex 2010, page 5, 3d ¶. There is 20
no convincing evidence in this record suggesting that the use of the 21
temperatures suggested in British 851 would not function for the purpose 22
stated in Canada 867. 23
(7) 24
Ashurst states (Paper 77, page 11:21 through page 12:2 [citations 25
omitted]): 26
59
Finally, early in the GSK development project, DuPont 1
recommended against using fluoropolymer coatings together 2
with HFA propellants. It is noted that the GSK claims are 3
limited to two specific HFA propellants. 4
The early GSK development occurred prior to publication of Canada 5
867. Moreover, we have declined to credit the "DuPont recommendation." 6
Even if the "DuPont recommendation" was credible, Dr. Batzar and the prior 7
art tells us that one skilled in the art would use a blend coating to overcome 8
the adherence problem associated with use of polytetrafluoroethylene in 9
non-blend form. 10
While the claims may be limited to using two specific fluorocarbon 11
propellants, it turns out that both are the only specific and preferred 12
fluorocarbon propellants mentioned in Canada 867. Ex 2010, page 5, 2d full 13
¶:1-2. Moreover, the record reveals that the two fluorocarbons are those 14
approved for use by the FDA. Ex 1007, page 20, (105). 15
(8) 16
Ashurst argues (Paper 77, page 12:3 through page 13:2 [citations 17
modified to conform citations in this opinion] ): 18
Even if it had been recognized that the degradation and 19
delamination rendered fluorocarbon polymers insufficient to 20
overcome the drug deposition problem, there were not a limited 21
number of identified predictable solutions to the drug 22
deposition problem. An invention can be obvious if there is 23
motivation for a change and there are “a finite number of 24
identified, predictable solutions,” KSR, supra, [127 S. Ct. at 25
1742,] 82 USPQ2d at 1397. As discussed above, there was no 26
60
apparent reason to modify the prior art in the first instance. 1
Additionally, there were not a limited number of predictable 2
solutions to the drug deposition problem. Many possible 3
solutions to the drug deposition problem were available for 4
consideration, many of which had nothing to do with coating 5
the inside of an MDI with a polymer (AFs 8-22). Even if a 6
decision had been made to try other polymers to solve the 7
unrecognized polymer adhesion problem, Novartis’ own 8
“expert” testified that there are “countless” polymers (Ex 2089, 9
page 125:21 through page 126:3), including specific 10
fluorocarbon copolymers (see Ex 2089, page 179:1 through 11
page 181:3 and page 207:9-21 which discusses Brugger Ex 12
1039 (U.S. Patent 3,194,428, which suggests at col. 2:37-51 13
that a certain type of fluorocarbon copolymer can be used if 14
adhesion is a problem) that could be investigated to further 15
improve on the specific polymers disclosed by Brugger (AF 16
102). There is nothing in the Brugger disclosure or the prior art 17
to suggest that the various “plastics coatings” would not solve 18
the drug deposition problem. 19
(a) 20
Ashurst has taken the "countless" polymers discussion in the Gupta 21
cross-examination out of context. The discussion in Ex 1089, page 125:21, 22
concerns the meaning of "plastics" as described in Canada 867. All can 23
agree in the abstract that the "term" plastics standing alone covers many 24
different types of materials—some of which might be useful in coating the 25
inner surface of an MDI and some which may not. 26
61
However, the term "plastics" in Canada 867 has to be viewed in 1
context as being a plastic that would adhere to the inner side walls of an 2
MDI container. One skilled in the art would have known that "plastics" 3
described in the British patents would have been suitable materials which 4
would adhere to the walls of an MDI. The use of a plastic other than 5
polytetrafluoroethylene with known better adherence properties is not 6
inconsistent with the description of "plastics" in Canada 867. 7
(b) 8
Ashurst argues that there are a lot of possible "blend coatings" which 9
could be "tried" and therefore this case does not involve the KSR "obvious to 10
try" rationale. According to Ashurst, the number of options is not finite. In 11
our view, Ashurst's argument misses the point and amounts to nothing more 12
than a transparent attempt to pigeon hole the facts here into the KSR 13
"obvious to try." There is no "obvious to try" issue involved in this case. 14
Canada 867 reveals that drug sticking to the inside of an MDI 15
container can be solved by coating the inside with polytetrafluoroethylene. 16
While the Brugger inventors named in Canada 867 application may not have 17
actually recognized it, those engaged in the polytetrafluoroethylene coating 18
art recognized that there are adherence problems with polytetrafluoro-19
ethylene polymers. Various solutions to those problems are suggested in the 20
British patent specifications. Dr. Batzar says he would not have used a 21
polytetrafluoroethylene by itself. Thus, the obvious solution to lack of 22
adherence problems with polytetrafluoroethylene includes using a blend of 23
polytetrafluoroethylene and a non-fluorinated polymer. 24
Several non-fluorinated polymers are suggested in the prior art. Some 25
of those suggested non-fluorinated polymers were commercial products 26
being marketed. See, e.g., Ex 1004, col. 4:46-58, which reveals one such 27
62
commercial products as being PTFE-PES DuPont 3200-100—it being 1
remembered that DuPont provides bulletins suggesting how the buyer might 2
use the product. The British patent specifications tell one skilled in the art 3
that the properties differ depending on a variety of factors, including the 4
non-fluorinated polymer used, the amount of both the polytetrafluoro-5
ethylene and non-fluorinated polymer, the nature of the non-fluorinated 6
polymer. 7
When the non-fluorinated polymers are combined with 8
polytetrafluoroethylene to make a blend, no one should be surprised that 9
better adherence is obtained. Why? Because the British patent 10
specifications tell one skilled in the art that that is exactly what will happen. 11
(c) 12
Another problem with the Ashurst argument is that it is a "divide and 13
conquer" argument. Cf. In re Young, 56 CCPA 757, 760, 403 F.2d 754, 757 14
(CCPA 1968) (obviousness rejection cannot be overcome by attacking 15
references individually). The argument declines to come to grips with the 16
fact that the prior art includes more than just the invention described in 17
Canada 867. 18
(9) 19
Ashurst argues (Paper 77, page 13:9-17) (citations and some other 20
material omitted): 21
Although "non-stick" coatings including "blend" coatings were 22
known in the cookware industry, the conditions and 23
requirements in the cookware industry make the applicability of 24
"cookware" and "bakeware" coatings unpredictable in 25
application to a MDI…However, unlike industrial applications, 26
any coating on the inside of a MDI canister would be in 27
63
prolonged and constant contact with the drug formulation, and 1
any coating failure in the life of the MDI product would not be 2
acceptable. 3
What Ashurst is saying is that one skilled in the art would not be able 4
to bridge the technological difference between cookware and MDIs. 5
Unfortunately for Ashurst, Canada 867 yells us otherwise. Canada 867 6
reveals that polytetrafluoroethylene used in other known environments is 7
also useful in MDI technology. 8
(10) 9
Ashurst makes reference to several Japanese patent documents. 10
Paper 77, page 14:2-9, indicating that if the Board wants those documents 11
made of record, Ashurst is happy to do so. We have no idea why the 12
discussion was presented given that both parties told Judge Medley that the 13
documents are not relevant to issues in this case. Paper 63, page 2. Like the 14
parties, it follows that the Board is not interested in the documents. 15
(11) 16
Ashurst asks us to weigh the testimony of the witnesses that have 17
testified in the proceeding. Paper 77, page 14:19 through page 15:9. 18
We have weighed the conflicting testimony and we find—for reasons 19
already given—that the testimony of Dr. Gupta and Dr. Singh is generally 20
more credible to the extent that it conflicts with that of the "expert" and fact 21
witnesses called by Ashurst. 22
As explained earlier, we have found that the Gupta and Singh 23
testimony is more faithful to the prior art and the content of the 24
specifications of the patent and application involved in the interference. 25
64
(12) 1
Ashurst makes what appears to be a due process argument (Paper 77, 2
pages 15:18-16:6): 3
When Dr. Singh was cross-examined on his Declaration 4
(submitted in support of Brugger Motion 1), he was asked 5
questions regarding blend coatings. Dr. Singh was instructed 6
not to answer the questions (AF 103). In Paper 46, permission 7
was given to Brugger to withdraw a further Declaration of 8
Dr. Singh (Ex 1032) that was submitted in opposition to 9
Ashurst Motions and to file substitute oppositions to the 10
Ashurst Motions, which had the effect of preventing further 11
cross-examination of this witness. Therefore, on the critical 12
“blend issue” Brugger is left with only (1) attorney argument 13
and (2) the testimony of Dr. Gupta, the expert provided by 14
Brugger who has no experience with pharmaceutical aerosol 15
products, MDIs, and CFC or HFA propellants. 16
Since Dr. Singh did not testify on direct concerning blend coatings, 17
there was no occasion to cross-examine him on blend coatings. Cross-18
examination is to be restricted to the subject matter of direct testimony. 19
Brugger relies on Dr. Gupta for testimony concerning blends. There 20
is no Ashurst contention that it did not have a full and fair opportunity to 21
cross-examine Dr. Gupta on blend coatings. 22
(13) 23
According to Ashurst, the reason that the blend issue is so critical is 24
that MDI cans coated with a blend coating unexpectedly prevents drug 25
deposition at least as much as pure fluorocarbon polymer. Paper 77, 26
65
page 16:7-9. To complete the argument, we would add that the blends 1
adhere better to the MDI can. 2
There is no credible evidence, commensurate in scope with any claim 3
involved, that a blend coating "unexpectedly" prevents drug deposition "as 4
much as pure fluorocarbon polymers." The "stratification" which takes 5
place in blends—discussed by both Dr. Batzar and the British patent 6
specifications—reveals why the Ashurst contention does not withstand 7
scrutiny. The surface inside an MDI coated with a blend coating is mostly 8
fluorocarbon polymer (which means drugs do not stick) and the surface of 9
the blend coating adhered to the MDI wall is non-fluorocarbon polymer 10
(polymers known to stick better to the wall). 11
(14) 12
Ashurst compares this case to Takeda Chemical Industries, Ltd. v. 13
Alphapharm Pty., Ltd., 492 F.3d 1350 (Fed. Cir. 2007), a case involving 14
obviousness of structural changes to pharmaceutical organic compounds. 15
Paper 77, page 16:18 through page 17:16. 16
Missing from Takeda, but present here, were prior art teachings 17
equivalent to those present in this case—the British patent specifications. 18
Brugger is said to have failed to cast the "mind" of the person of 19
ordinary skill in the art back to the time when the invention was made. 20
Paper 77, page 17:12. The relevant time is not when the invention was 21
"actually made." If an invention would have been obvious more than one 22
year before a patent application is filed, it does not matter when or how long 23
ago the invention might have been made. In re Foster, 52 CCPA 1808, 343 24
F.2d 980 (CCPA 1965). While prior art right up to Ashurst's filing date 25
would be relevant on this record—since Ashurst will not put on any priority 26
evidence—we have considered the prior art in existence more than about one 27
66
year prior to Ashurst's filing date. Essentially that means Canada 867 and 1
the other prior art we have discussed. We have an obligation to avoid any 2
hindsight bias. Muniauction, Inc. v. Thomson Corporation, No. 2007-1485, 3
slip op. at 10 (Fed. Cir. July 14, 2008). Since Brugger's position, and our 4
rationale, is bottomed on that prior art, we firmly believe that no hindsight 5
reconstruction has occurred in this case. In re McLaughlin, 58 CCPA 1310, 6
1313-14, 443 F.2d 1392, 1395 (CCPA 1971) (obviousness judgments are 7
necessarily based on hindsight; so long as judgment takes into account only 8
knowledge known in the art, there is no error) 9
(15) 10
In requesting additional briefing the Board asked for input on why 11
research efforts prior to publication of Canada 867 are relevant to the 12
obviousness inquiry before us. In addition, we asked for input on whether 13
one relying on a long-felt want must establish that those trying to solve the 14
want were aware of the prior art, citing Toledo Pressed Steel Co. v. Standard 15
Parts, Inc., 307 U.S. 350, 356 (1939), and In re Allen, 51 CCPA 809, 814, 16
324 F.2d 993, 997 (1963). Paper 65, page 5. 17
Ashurst has provided a response. Paper 77, page 18:1 through 18
page 25:17. 19
(a) 20
At the outset, we believe that a long-felt want which is solved by an 21
invention is relevant to the obviousness inquiry. However, it is only one 22
factor to be considered and must be weighed against the scope and content 23
of the prior art. Solving a long-felt want does not per se result in a holding 24
of non-obviousness. Some long-felt want solutions would have been 25
obvious and others would not. 26
(b) 27
67
Ashurst notes that it attempts to solve the coating adherence problem 1
started long before publication of Canada 867 (Paper 77, page 18, 8-10) and 2
that once Canada 867 was published the effect should have been to stop 3
further research—the invention of Canada 867 supposedly having solved the 4
problem (Paper 77, page 18:21 through page 19:3). Since that did not 5
happen, Ashurst reasons that its blend coating solved the long-felt want. 6
Despite its research efforts prior to publication of Canada 867, one 7
skilled in the art would nevertheless view the invention described in Canada 8
867 as significant. The argument that further research was not needed is 9
belied by the facts. All those with knowledge of polytetrafluoroethylene 10
recognized that it had adherence problems—at least for MDIs to be 11
commercially marketed. Brugger claims, and Ashurst at one time claimed, 12
MDIs coated only with polytetrafluoroethylene, which is an 13
acknowledgement of at least a scientific (albeit not necessarily a 14
commercial) advance. Those skilled in the art, by virtue of the British patent 15
specifications, would have known that polytetrafluoroethylene would not 16
have been the ideal commercial coating due to possible adherence problems. 17
The British patent specifications tell one skilled in the art how to solve the 18
problem which results from use of polytetrafluoroethylene. 19
Ashurst goes on to say that its "blend solution" is a superior resolution 20
of the problem and the previously unrecognized problem of coating 21
degradation and delamination. Paper 77, page 19:12-14. While all 22
recognize that the blend produces better adhesion, so does the prior art. 23
Accordingly, there is no convincing evidence that the Ashurst solution is 24
unexpected. 25
(c) 26
68
Ashurst maintains that there is no requirement that those working in 1
the field, i.e., the Ashurst inventors, must have known of the prior art before 2
Ashurst can maintain a "long-felt" want and a "solution" thereto. According 3
to Ashurst, the statements in earlier decided Toledo Pressed Steel and In re 4
Allen are inconsistent with later decided Graham v. John Deere Co. In 5
support of its position, Ashurst cites (1) Advanced Display Systems, Inc. v. 6
Kent States University, 212 F.3d 1272, 1284-85 (Fed. Cir. 2000) (long-felt 7
need simply requires evidence of failed attempts by others) and (2) Hodosh 8
v. Block Drug Co., 786 F.2d 1136, 1144 (Fed. Cir. 1986) (evidence of 9
secondary considerations is considered independently of what any real 10
person [, i.e., the Ashurst inventors,] knows about the prior art.). Lastly, 11
Ashurst quotes from Graham v. John Deere Co., 383 U.S. 1, 36 (1966), that 12
'[i]t is also irrelevant that one apparently chose to avail himself of 13
knowledge stored in the Patent Office and readily available by the simple 14
expedient of conducting a patent search—a prudent and nowadays common 15
preliminary to well organized research." [citation omitted]. 16
(i) 17
While a long-felt unsolved need is manifestly relevant to obviousness, 18
also relevant is a relatively prompt solution to a problem encountered in 19
industry. 20
The Ashurst argument would be more compelling if Canada 867 had 21
not been published. If Canada 867 had not been published and had Ashurst 22
been the first to file a patent application with a coating on the inside of an 23
MDI, then a different case would be before us. But, Canada 867 was 24
published (28 February 1995) and Ashurst application was filed a little more 25
than 14 months later (11 April 1996). 26
69
From the perspective of one having ordinary skill in the art charged 1
with knowledge of the relevant prior art, it is hard to see why the 14-month 2
period (or a shorter period if an unrelied upon Ashurst provisional 3
application is considered), even if characterized as a "long-felt" want of an 4
unsolved problem, is entitled to more weight than the explicit teachings of 5
the prior art as a whole. One skilled in the art would not have known what 6
went on behind closed doors of the Ashurst assignee's research efforts—at 7
least on this record we are not told that those efforts were "open to the 8
public." 9
(ii) 10
As we see the issue, the public and those skilled in the art knew 11
(1) coating an MDI can with polytetrafluoroethylene minimized drug 12
deposition on the inside of the MDI can; (2) polytetrafluoroethylene, while a 13
technical solution and a useful advance in-and-of itself, had adherence 14
problems; (3) blend coatings comprising polytetrafluoroethylene and a non-15
fluorinated polymer had better adhesion properties; and (4) due to 16
stratification, the non-fluorinated polymer adhered to the inside of the MDI 17
can wall and the polytetrafluoroethylene ended up in contact with the 18
propellant and drug. 19
The Supreme Court has consistently held that those skilled in the art 20
are entitled to use known information for its known purpose and unless some 21
unexpected result is obtained, the use most often would have been obvious. 22
KSR, Anderson's-Black Rock, Inc. v. Pavement Salvage Co., Inc., 396 U.S. 23
57 (1969); Graham v. John Deere Co. That is what seems to have happened 24
in this case. Ashurst used the known polymers described in the British 25
patent specifications for their known purpose and achieved an expected 26
result. 27
70
(iii) 1
Starting an obvious analysis from 28 February 1995, when Canada 2
867 was published, is consistent with observations by the Supreme Court in 3
Graham v. John Deere Co., 383 U.S. at 36: "[a]t the latest, those 4
differences were rendered apparent in 1953 by the appearance of the 5
Livingston patent, and unsuccessful attempts to reach a solution to the 6
problems confronting Scoggin made before that time became wholly 7
irrelevant." See also Newell Companies v. Kenny Mfg. Co., 864 F.2d 757, 8
768 (Fed. Cir. 1988) (although at one time there was a long-felt need, once 9
another supplied a key element to solve the need, there was no long-felt need 10
or problem to be solved). 11
(16) 12
Ashurst presents the following commercial success argument 13
(Paper 77, page 24:17 through page 25:17) (citations to the record omitted; 14
bracketed matter added): 15
With respect to commercial success, GSK developed and 16
currently markets 3 HFA MDI product lines which employ an 17
aluminum can internally coated with a blend of fluorocarbon 18
and non-fluorocarbon polymers, namely a PTFE/PES blend. 19
After review of extensive testing and data, the FDA approved 20
GSK’s blend-coated Ventolin®, Flovent® and Advair® HFA 21
MDI products. In 2006, combined sales were over $748 22
million on over 4.4 million prescriptions. 23
The record establishes that in U.S. 6,511,653 [involved in 24
Interference 105,624] , at least claims 1, 7-12, 14 and 20-23 25
cover a GSK commercial product. The record does not 26
establish the thickness, nature or ratio of the blend coating used 27
71
in the GSK commercial products. This statement should not be 1
taken as an admission that other claims in this and other GSK 2
patents do not cover GSK commercial products. 3
In view of the fact that the claims identified above cover 4
one or more of GSK’s commercial products and also contain 5
the blend limitation, on this record, a nexus should be presumed 6
and the evidence of commercial success should be considered. 7
See, e.g., J. T. Eaton & Co. v. Atlantic Paste & Glue Co., 106 8
F.3d 1563, 1571 … (Fed. Cir. 1997). Furthermore, since the 9
broadest claims in the ‘653 patent cover all of GSK’s 10
commercial products, it is submitted that all claims in this 11
patent should be designated as not corresponding to the count. 12
The fact that the features of certain narrower claims might have 13
not yet been incorporated into a commercial product does not in 14
any way negate the patentability of those claims. 15
We understand Ashurst to say that a nexus should be presumed based 16
on the following statement in Eaton: "[w]hen a patentee can demonstrate 17
commercial success, usually shown by significant sales in a relevant market, 18
and that the successful product is the invention disclosed and claimed in the 19
patent, it is presumed that the commercial success is due to the patented 20
invention." Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 21
1387, 1392 (Fed. Cir. 1988)." See also Tec Air Inc. v. Desno Manufacturing 22
Michigan Inc., 192 F.3d 1353, 1361 (Fed. Cir. 1999). 23
72
(a) 1
The commercial success nexus "presumption" supposedly announced 2
by the Federal Circuit in Eaton, Demaco and Tec Air is inapplicable in 3
proceedings before the Board. Why? The three cases involved appeals from 4
patent infringement litigation in district court. The discovery tools available 5
under the Fed. R. Civ. P. allow an accused infringer to discover evidence 6
relevant to nexus through interrogatories, admissions and discovery 7
depositions. These tools are not as readily available in an interference. 8
Discovery in an interference is not the same as discovery under the Fed. R. 9
Civ. P. See (1) Frilette v. Kimberlin, 508 F.2d 205 (3d Cir. 1974) (en banc), 10
cert. denied, 421 U.S. 980 (1985) (Patent Office discovery not as liberal as 11
the Federal Rules of Civil Procedure); (2) Cook v. Dann, 522 F.2d 1276 12
(CCPA 1975) (the additional discovery rule [37 C.F.R. § 41.150(c) (2007)] 13
"does not bestow the right to discovery of unlimited scope."); and (3) 14
Sernyk v. DeBonte, 72 USPQ2d 1355, 1361 (Bd. Pat. App. & Int. 2004) (the 15
scope of discovery under board rules is the same as that of the Fed. R. Civ. 16
P.). 17
If a presumption is to be created, the party against whom the 18
presumption applies must have a fair opportunity to overcome the 19
presumption. In a civil action that opportunity is available through liberal 20
discovery. In an interference it is not. Accordingly, we decline to apply the 21
presumption made applicable by the Federal Circuit in patent infringement 22
cases to patent interferences which are governed by limited discovery rules 23
established by the Director. 24
(b) 25
Assuming the presumption applied in interferences, there is an answer 26
to why commercial success should nevertheless be accorded little, if any, 27
73
weight in this case. The patents involved in the four interferences issued in 1
2003. The sales to which reference is made in Paper 77 occurred in 2006. 2
In the face of those patents, it is hard to imagine another trying to 3
enter the market. Cf. (1) Syntex (U.S.A.) LLC v. Apotex, Inc., 407 F.3d 1371, 4
1383 (Fed. Cir. 2005) (evidence of commercial success can result in a weak 5
inference when prior art patents prevents others from competing to reach the 6
solution embodied in the claims at issue) and (2) Merck & Co., Inc. v. Teva 7
Pharmaceuticals USA, Inc. 395 F.3d 1364, 1377 (Fed. Cir.), request for 8
rehearing in banc denied, Gillette Co. v. Energizer Holdings, Inc. 405 F.3d 9
1338 (Fed. Cir. 2005) (because market entry by others was precluded, the 10
inference of non-obviousness of weekly-dosing, from evidence of 11
commercial success, is weak). 12
(17) 13
We asked the parties to present a short history describing the nature of 14
MDI approvals by the FDA. Paper , 65, page 6. 15
Ashurst responded with a lengthy discussion. Brugger says there is 16
not much in the record. 17
FDA approval is not a condition for unobviousness. In re Anthony, 18
56 CCPA 1443, 414 F.2d 1383 (CCPA 1969). 19
However, to the extent that an FDA approved device is the basis for a 20
commercial success argument, the precise nature of the device should be 21
manifest on the record. Ashurst admits that those details are not established 22
on the record. Paper 77, page 25:4-6. Accordingly, we think further 23
discussion of the FDA approval process is not necessary, or appropriate, on 24
this record. 25
74
Other Ashurst arguments 1
We have considered all of Ashurst’s remaining arguments and find 2
none that warrant granting the relief requested by Ashurst. Cf. Hartman v. 3
Nicholson, 483 F.3d 1311, 1315 (Fed. Cir. 2007). 4
Patentability of Brugger claims 1-19 5
In our order asking for additional briefing, we requested that the 6
parties present their views on whether Brugger claims 1-19 are unpatentable 7
under 35 U.S.C. § 103 over the prior art. Paper 65, page 7:4 through 8
page 8:9. 9
Ashurst does not challenge the patentability of Brugger claims 1-19. 10
Paper 77, page 27. 11
Brugger has presented its views and maintains that Brugger 12
claims 1-19 are patentable under 35 U.S.C. § 103. Paper 72. 13
In this interference, as well as Interferences 105,624 through 105,626, 14
we decline to reach the issue of whether Brugger claims 1-19 are 15
unpatentable under 35 U.S.C. § 103 over the prior art. 16
First, Ashurst does not contest the patentability of Brugger 17
claims 1-19. 18
Second, there is no motion for judgment before us urging 19
unpatentability of Brugger claims 1-19 over the prior art and therefore 20
Brugger has not had a full and fair opportunity to develop any non-21
obviousness issue before us. 22
Third, while Canada 867 and the subject matter of Count B is prior art 23
to Ashurst, neither is prior art vis-à-vis Brugger. 24
Fourth, since Brugger is involved on the basis of an application, the 25
Examiner is free to consider patentability when the interference is over. 26
Krasnow v. Bender, 36 CCPA 723, 728, 170 F.2d 560, 564 (CCPA 1948) 27
75
(prosecution may be reopened after favorable decision in an interference; 1
"[t]he Patent Office is not bound to issue a patent to an applicant who 2
prevails in an interference proceeding …."). Nothing we say in this opinion 3
should be construed as precluding the Examiner from rejecting any of 4
Brugger's claims 1-19 if the Examiner be so advised. 5
Decision 6
We substitute Count B for Count 1 because it defines the common 7
subject matter claimed by Ashurst and Brugger. 8
Ashurst Motion 1 is dismissed as moot to the extent that Count A will 9
not be substituted for Count 1, but is granted to the extent that we have 10
substituted Count B for Count 1. 11
Ashurst Motion 1 is denied to the extent that Ashurst claim 23 will be 12
designated as corresponding to Count B (and would have been designated as 13
corresponding to either original Count 1 or proposed Count A). 14
Brugger Substitute Motion 1 is granted to the extent that Ashurst 15
claim 23 will be designated as corresponding to Count B. 16
Since Ashurst does not intend to present proofs on the issue of 17
priority, then we award priority against Ashurst. 18
Ashurst claims 1-25 are unpatentable under (1) 35 U.S.C. 19
§ 102(g)/103 based on Ashurst having not prevailed on priority: the subject 20
matter of Count B alone or the combination of the subject matter of Count B 21
and the prior art. 22
Because Canada 867 (which essentially identical to the involved 23
Brugger application), it is also manifest that Ashurst claims 1-25 are also 24
unpatentable under 35 U.S.C. § 102/103 over Canada 867 and the prior art. 25
A judgment is entered in a separate paper (Paper 84). 26
76
F. Brugger Motion 2 1
Brugger Motion 2 seeks to exclude from evidence parts or all of some 2
exhibits offered by Ashurst. 3
In ruling on the admissibility of some of the objected to evidence, we 4
have taken into account that (1) Ashurst has not prevailed, (2) in considering 5
the objections to the admissibility of the evidence we have looked at the case 6
somewhat in a light most favorable to Ashurst, and (3) in large we have not 7
accorded little, if any, weight to the objected to evidence. 8
We also wish to make clear that we have not admitted any of the 9
evidence based on the business record exception to the hearsay rule. 10
Exhibit 2008 11
Brugger seeks to exclude the direct testimony of Dr. Britto (Ex 2008, 12
¶¶ 5-8, 19 and 22) on the ground that it is "expert" testimony but Dr. Britto 13
was not offered as an "expert." The objection is overruled. While Dr. Britto 14
was not offered as an "expert," his day-to-day work was in the field. He was 15
involved at Glaxo trying to solve MDI problems, and is allowed to give his 16
impressions of the state of MDI use at the time Glaxo was trying to solve the 17
problems. 18
Brugger seeks to exclude the direct testimony of Dr. Britto (Ex 2008, 19
¶¶ 9-16) on the ground that it is hearsay. The objection is overruled. In ¶ 9, 20
Dr. Britto testifies that in the early part of 1994, he was aware that Glaxo 21
had been investigating numerous ways to address the drug deposition and 22
dosing reproducibility problem. Dr. Britto goes on to say why he was 23
aware, relying on some hearsay memos. We see no problem with 24
Dr. Britto's testimony. He certainly can testify as to what he was aware. 25
The fact that Dr. Britto's awareness is based on hearsay documents goes to 26
the weight to be given his testimony, not its admissibility. The fact is he 27
77
believed, for whatever reason, that Glaxo was engaged in trying to solve a 1
problem. We have no reason to doubt his belief and it is permissible to say 2
why he had his impression. 3
Exhibit 2028 4
Brugger seeks exclude some of Dr. Herman's testimony on the ground 5
it is hearsay. Essentially, Brugger says Dr. Herman is not entitled to rely on 6
hearsay documents to support his testimony. The objection is overruled. 7
Dr. Herman's testimony relates to why there was "initial skepticism" about 8
the use of fluoropolymers. His impression was that there was skepticism. 9
Why? Because there were Glaxo documents, albeit hearsay documents, 10
which so indicated. Dr. Herman is permitted to testify as to his mental 11
impression at a particular time. 12
Exhibit 2030 13
Exhibit 2030 is a report of activity said to have taken place at Glaxo. 14
Dr. Britto testified concerning the report. Dr. Britto was personally involved 15
in preparation of the report. Brugger objects to the admissibility of the 16
report based on its being hearsay. The objection is overruled. Dr. Britto 17
relied on the report to testify concerning his impression of what Glaxo had 18
done and where Glaxo should go from there. The real problem with the 19
report is one of weight. Assuming the events in the report took place before 20
its date (03 February 1995), those events took place prior to publication of 21
Canada 867. Activities taking place prior to publication of Canada 867, 22
while interesting, took place prior to the first published suggestion that 23
fluoropolymers could be used in MDIs. Moreover, the results described in 24
the repot are not commensurate in scope with the breadth of the claims. 25
78
Exhibit 2031 1
Exhibit 2031 is a copy of an email facially sent by a Michael Riebe 2
and actually received by Dr. Herman. Brugger objects to its admissibility on 3
the ground it was not authenticated. Dr. Herman testified that he received 4
the email. Nothing more is needed to establish authenticity. 5
Brugger also says the content of the email is hearsay. The email 6
suggests the use of a fluoropolymer. Dr. Herman can certainly testify that it 7
was his impression that use of a fluoropolymer had been suggested. Why? 8
Because, he had received an email to that effect. So as far as Dr. Herman is 9
concerned, the suggestion was made and that is the extent of his testimony. 10
Brugger's objections are overruled. 11
Exhibit 2033 12
Exhibit 2033 is an email facially sent by Patrick Kaczaral and actually 13
received by Dr. Herman. The email indicates that Dr. Kaczaral is going to 14
contact DuPont to find out whether there are certain problems. The email is 15
dated 14 January 1994. On the email are handwritten notes made by 16
Dr. Herman on or about 17 January 1994. Among other things, the 17
handwritten notes say (based on an apparent conversation between 18
Dr. Herman and Dr. Kaczaral) that DuPont recommends against using 19
Teflon® . Brugger claims the written notes are hearsay and objects to the 20
admissibility of Exhibit 2033. The objection is overruled. Dr. Herman can 21
testify as to what he wrote. His impression is that Dr. Kaczaral talked with 22
someone at DuPont and received a negative recommendation from DuPont. 23
Those are Dr. Herman's impressions and are plainly admissible. We have 24
given little weight to the alleged DuPont communications because no one 25
testified concerning those communications. Moreover, the communications 26
took place before publication of Canada 867. 27
79
Exhibit 2034 1
Exhibit 2034 is an email facially sent by Michael Riebe and actually 2
received by Dr. Herman. The email is facially dated 18 January 1994 and 3
indicates that preliminary studies with fluoropolymers may not be 4
acceptable. Brugger objects to admissibility on hearsay grounds. The 5
objection is overruled. Dr. Herman is entitled to rely on the email to give his 6
impressions. Moreover, the email is dated prior to publication of Canada 7
867 and therefore is entitled to little weight. 8
Exhibit 2053 9
We have not found it necessary to consider or rely on Exhibit 2053. 10
Accordingly, we do not reach Brugger's objection to the admissibility of 11
Exhibit 2053. 12
Exhibit 2058 13
Exhibit 2058 is a "report" apparently dated 7/16/95 (which we take to 14
mean 16 July 1995) on the status of MED can coating program for 134a 15
products. Brugger objects to its admissibility on the ground of hearsay. The 16
objection is overruled. The report is an internal Glaxo document. Both Dr. 17
Britto and Dr. Dalby gave their impressions of the status of research at 18
Glaxo based on the report. They are both entitled to do so. 19
G. Order 20
Upon consideration of the motions, and for the reasons given, it is 21
ORDERED that Ashurst Motion 1 is granted to the extent that 22
Count B is substituted for Count 1. 23
FURTHER ORDERED that Ashurst Motion 1 is denied to the 24
extent that it seeks to have Count A substituted for Count 1. 25
80
FURTHER ORDERED that Ashurst Motion 1 is denied to the 1
extent that Ashurst seeks to have claim 23 of Ashurst Patent 6,511,652 B1 2
designated as not corresponding to Count B. 3
FURTHER ORDERED that, as to Interference 105,482, 4
Ashurst Motion 1 is otherwise dismissed. 5
FURTHER ORDERED that Brugger Substitute Motion 1 is 6
granted to the extent that Ashurst claims 21 and 23 will be designated as 7
corresponding to Count B. 8
FURTHER ORDERED that priority of invention of the subject 9
matter of Count B is awarded against Ashurst. 10
FURTHER ORDERED that Ashurst is not entitled to a patent 11
containing claims 1-24 of Ashurst Patent 6,511,652 B1. 12
FURTHER ORDERED that, as to Interference 105,482, 13
Ashurst Motion 2 is dismissed. 14
FURTHER ORDERED that Brugger Motion 2 is denied. 15
81
cc (via electronic mail): 1
2
Attorneys for Ashurst 3
(real party in interest 4
SmithKlein Beecham Corp.): 5
6
Gerald M. Murphy, Jr., Esq. 7
BIRCH, STEWART, KOLASH & BIRCH, LLP 8
8110 Gatehouse Road, Suite 100 East 9
Falls Church, VA 22042 10
11
Tel: 703-205-8000 12
Fax: 703-205-8050 13
Email: mailroom@bskb.com 14
15
Peter J. Armenio, Esq. 16
KIRKLAND & ELLIS LLP 17
153 East 53d Street 18
New York, NY 10022 19
20
Tel: 212-446-4960 21
Fax: 212-446-4900 22
Email: parmenio@kirkland.com 23
24
Attorney for Brugger 25
(real party in interest 26
Novartis Corporation): 27
28
James J. Kelly, Esq. 29
OBLON, SPIVAK, McCLELLAND, MAIER & NEUSTADT, P.C. 30
1940 Duke Street 31
Alexandria, VA 22314 32
33
Tel: 703-412-6485 (direct) 34
Fax: 703-413-2220 35
Email jkelly@oblon.com 36
37
(continued on next page) 38
39
40
82
Gregory C. Houghton, Esq. 1
NOVARTIS CORPORATION 2
Corporate Intellectual Property 3
One Health Plaza, Building 430 4
East Hanover, NJ 07936-1080 5
6
Tel: 862-778-2614 (direct) 7
Fax: 973-781-8064 8
Email: gregory.houghton@novartis.com 9
10